scholarly journals The Safety of Substitution of Antiretroviral Regimen in Non-Clinical Trial Settings in Asian Countries

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S432-S432
Author(s):  
In Young Jung ◽  
David Boettiger ◽  
Wingwai Wong ◽  
Man Po Lee ◽  
Sasisopin Kiertiburanakul ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Virological Failure ◽  
Drug Class ◽  
Virologic Failure ◽  
Asian Countries ◽  
Major Treatment ◽  
A Minor ◽  
Substitution Group ◽  
Median Rate

Abstract Background Although substitutions of antiretroviral regimen are generally safe, most data on substitutions are based on results from clinical trials. The objective of this study was to evaluate the safety of substituting antiretroviral regimen in virologically suppressed HIV-infected patients in non-clinical trial settings in Asian countries. Methods HIV-infected patients enrolled in the TREAT Asia HIV Observational Database (TAHOD) were included in this analysis if they started combination antiretroviral therapy (cART) after 2002, were being treated at a center that documented a median rate of viral load (VL) monitoring ≥ 1 tests/patient/year, and experienced a minor or major treatment substitution while on virally suppressive cART (VL < 200 copies/mL). Minor regimen substitutions were defined as within-class changes and major regimen substitutions were defined as changes to a drug class. Virologic failure was defined as having had two viral load measurements > 400 copies/mL. The patterns of substitutions and rate of virologic failure after substitutions were analyzed. Results Of 3,994 adults who started ART after 2002, 3,119 (78.1%) had at least one period of virological suppression. Among these, 1,170 (37.5%) underwent a minor regimen substitution, and 296 (9.5%) underwent a major regimen substitution during suppression. The rates of virological failure were 1.48/100person years (95% CI 1.14–1.91) in the minor substitution group and 2.85/100person years (95% CI 1.88–4.33) in the major substitution group, and 2.53/100person years (95% CI 2.20–2.92) among patients that did not undergo a treatment substitution. Conclusion The rate of virological failure was relatively low in both major and minor substitution groups, showing that regimen substitution is generally safe in non-clinical trial settings in Asian countries. Disclosures All authors: No reported disclosures.

scholarly journals Detectable viral load among HIV -1 positive pregnant women on ART (Option B +) in northern Tanzania: Baseline results from the HIVDR study

2021 ◽  
Vol 3 (1) ◽  
pp. 44-50
Author(s):  
Nicholaus Steven Mazuguni ◽  
Festo Mazuguni ◽  
Eva Prosper Muro
Keyword(s):  
Drug Resistance ◽  
Viral Load ◽  
Virological Failure ◽  
Virologic Failure ◽  
Resistance Mutation ◽  
Resistance Testing ◽  
Resistance Mutations ◽  
Drug Resistance Mutations ◽  
Hiv 1 ◽  
Level Resistance

Introduction: In Tanzania, the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDEC) has implemented the Option B+ as one of the strategies to facilitate achievement of elimination of mother to child transmission of HIV. To prevent emergence of drug resistance mutations early identification of option B+ failure is critical. The emergence of drug resistance mutation and subsequent treatment failure poses a major concern for HIV program in low- and middle-income resource settings where treatment options are limited. Methodology: We recruited treatment naïve, treatment experienced HIV-1 positive pregnant women and those who had prophylaxis in their previous pregnancy in Kilimanjaro, northern Tanzania August 2016 to February 2017. Whole blood (2ml) for biochemistry, viral load and drug resistance testing were taken at baseline. ARV drug resistance testing was done on women with VL ≥ 1000 copies/ml. We used descriptive statistic and logistic regression to determine the strength of association between virologic outcome (virologic failure) and independent predictors. Results: One hundred and forty eight (148) pregnant HIV-positive women were enrolled in the study with mean age of 29.82 years (SD=6.17) from August, 2016 to February, 2017. Virologic failure was demonstrated in 34 (23%) with viral load   ≥ 1,000 copies/ml. Genotyping results were available from 26 women, mutations associated with ARV resistance were detected in 23.1% (n = 6/26). Among the six women with ARV resistance mutation 4(66.7%) had high level resistance and 2(33.3%) had low level resistance. Among the 26 samples genotyped 15(58%) viruses were subtype A, while eight were subtype C (31%) and three subtypes D (11%). The most dominant drug resistance mutations against the reverse transcriptase inhibitors for the women with high level resistance were K103N, Y188L, D67N, K70R, M184V, T215F, K219EQ, and the low-level resistance was E138A. The older age was associated with virological failure compared to those who were < 20 year of age. Conclusion: Viral load testing should be done on women who were already on antiretroviral treatment on their first antenatal visit to ensure early detection of virological failure and enable clinicians to take an appropriate course of action on their management. Educational intervention on adherence should be targeted at an early stage to women with virological failure during pregnancy to reduce the emergence of HIV-1 drug resistance mutations.

scholarly journals Determinants of Virologic Failure among Adult HIV Patients on First-Line Antiretroviral Therapy at Waghimra Zone, Northern Ethiopia: A Case-Control Study

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Abrham Emagnu ◽  
Zenahebezu Abay ◽  
Abera Balcha Bulti ◽  
Yaregal Animut
Keyword(s):  
Viral Load ◽  
Antiretroviral Therapy ◽  
Virological Failure ◽  
Drug Toxicity ◽  
Case Control Study ◽  
Virologic Failure ◽  
Case Control ◽  
Northern Ethiopia ◽  
Factors Associated ◽  
Control Study

Introduction. The primary goal of antiretroviral therapy (ART) is to reduce the viral load in HIV-infected patients to promote quality of life, as well as to reduce HIV-related morbidity and mortality. A high rate of virologic failure was reported in Waghimra Zone, Northwest Ethiopia, in viral load assessment conducted among HIV-infected patients on ART in the Amhara region. However, there is limited evidence on the determinants of virological failure in the study area. This study aimed to identify the determinants of virological failure among HIV-infected patients on antiretroviral therapy in Waghimra zone, Northern Ethiopia, 2019. Methods. An institutional-based unmatched case-control study was conducted from May 21 to June 30, 2019. Cases were people living with HIV (PLHIV) on ART who had already experienced virological failure; controls were those without virological failure. Data were extracted from 92 cases and 184 controls through chart review using a pretested and structured checklist. The data were entered using Epi Info version 7 and exported to SPSS version 20 for analysis. A multivariate logistic regression analysis was carried out to identify factors associated with virological failure, and variables with a P value <0.05 were considered statistically significant. Results. This study revealed that poor adherence to ART (adjusted odds ratio (AOR) = 4.24, 95% confidence interval (CI): 2.17, 8.31), taking ART for longer than five years (AOR = 3.11, 95% CI: 1.17, 8.25), having drug toxicity (AOR = 3.34, 95% CI: 1.54, 7.23), age of PLHIV ≥ 35 years (AOR = 2.45, 95% CI: 1.29,4.64), and recent CD4 count <200 cells/mm³ (AOR = 3.06, 95% CI: 1.52, 6.13) were factors associated with virologic failure. Conclusion and Recommendation. This study showed that poor adherence to treatment, longer duration on ART, experiencing drug toxicity, older age, and recent CD4 <200 cell/mm³ are factors that increase the risk of virologic failure.

scholarly journals Magnitude of virologic failure and associated factors among adult patients on antiretroviral therapy at Debre Markos Referral Hospital, Northwest Ethiopia, 2018

2020 ◽  
Author(s):  
Addisu Abebaw ◽  
Mekuanint Taddele ◽  
Girma Alem ◽  
Tesfa Birlew ◽  
sileshi Berihun
Keyword(s):  
Social Support ◽  
Viral Load ◽  
Adult Patient ◽  
Functional Status ◽  
Virological Failure ◽  
Associated Factors ◽  
Virologic Failure ◽  
Lower Income ◽  
Viral Load Monitoring ◽  
Load Monitoring

Abstract Background : Viral load monitoring is used as an important marker for diagnosing early treatment failure in patients with HIV infection/AIDS. Ethiopia has started targeted viral load monitoring recently. However, factors leading to virological failure are not well understood. The aim of this study is to assess magnitude of virologic failure and associated factors among adult patient on ART at Debre Markos Referral Hospital, North West Ethiopia. Methods : Cross sectional study was conducted on 304 participants who had started first line HAAR. Data were collected from patients’ chart starting from ART commencement and face to face interview using semi structured questionnaire. Viral load from separated plasma were analyzed according to protocols. The collected data were analyzed using SPSS version 20. Binary and multiple logistic regression models were fitted to identify factors associated with virological failure among adult patient on ART and to control confounding effect. The results were presented as odds ratio (OR) with 95% confidence intervals. Independent associations were considered with p<0.05. Results: Magnitude of virological failure was 10.5%. Lower income, (AOR = 3.5, 95% CI = 1.2 - 10.5, P = 0.024), lack of social support (AOR = 2.9, 95% CI = 1.01 – 8.2, P = 0.024), Interruption of ART, (AOR = 3.5, 95% CI = 1.01 – 12.1, P = 0.046), drug adherence (AOR = 3.6, 95% CI = 1.1 – 11.3, P = 0.028), non-working functional status (AOR = 3.5, 95% CI = 1.2 – 9.7, P = 0.018), WHO stage III or IV (AOR = 2.9, 95% CI = 1.01 – 8.0, P = 0.040), CD4 count < 200 cells/ml (AOR = 3.0, 95% CI = 1.1 – 8.0, P = 0.031) and TB co-infection (AOR = 3.7, 95% CI = 1.2 – 11.3, P = 0.018) were significantly associated with virological failure. Conclusions and recommendations : The prevalence of virologic failure was high. Lower income, lack of social support, interruption of ART, drug non-adherence, baseline non-working functional status, WHO stage, CD4 count < 200 cells/ml and TB co-infection Conducting faith healing, TB co infection, WHO stage III and IV, adherence, and income were determinants of virologic failure. Therefore early identification of associated factors and monitoring of virologic failure has to be strengthened to benefit patients to prevent from further complication. Keywords : HIV, virological failure, ART, Ethiopia

scholarly journals Predictors of virological failure among people living with HIV receiving first line antiretroviral treatment in Myanmar: retrospective cohort analysis

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Anita Mesic ◽  
Alexander Spina ◽  
Htay Thet Mar ◽  
Phone Thit ◽  
Tom Decroo ◽  
...  
Keyword(s):  
Viral Load ◽  
Virological Failure ◽  
Antiretroviral Treatment ◽  
People Living With Hiv ◽  
First Line ◽  
Hiv Viral Load ◽  
Loss To Follow Up ◽  
History Of ◽  
Living With Hiv

Abstract Background Progress toward the global target for 95% virological suppression among those on antiretroviral treatment (ART) is still suboptimal. We describe the viral load (VL) cascade, the incidence of virological failure and associated risk factors among people living with HIV receiving first-line ART in an HIV cohort in Myanmar treated by the Médecins Sans Frontières in collaboration with the Ministry of Health and Sports Myanmar. Methods We conducted a retrospective cohort study, including adult patients with at least one HIV viral load test result and having received of at least 6 months’ standard first-line ART. The incidence rate of virological failure (HIV viral load ≥ 1000 copies/mL) was calculated. Multivariable Cox’s regression was performed to identify risk factors for virological failure. Results We included 25,260 patients with a median age of 33.1 years (interquartile range, IQR 28.0–39.1) and a median observation time of 5.4 years (IQR 3.7–7.9). Virological failure was documented in 3,579 (14.2%) participants, resulting in an overall incidence rate for failure of 2.5 per 100 person-years of follow-up. Among those who had a follow-up viral load result, 1,258 (57.1%) had confirmed virological failure, of which 836 (66.5%) were switched to second-line treatment. An increased hazard for failure was associated with age ≤ 19 years (adjusted hazard ratio, aHR 1.51; 95% confidence intervals, CI 1.20–1.89; p < 0.001), baseline tuberculosis (aHR 1.39; 95% CI 1.14–1.49; p < 0.001), a history of low-level viremia (aHR 1.60; 95% CI 1.42–1.81; p < 0.001), or a history of loss-to-follow-up (aHR 1.24; 95% CI 1.41–1.52; p = 0.041) and being on the same regimen (aHR 1.37; 95% CI 1.07–1.76; p < 0.001). Cumulative appointment delay was not significantly associated with failure after controlling for covariates. Conclusions VL monitoring is an important tool to improve programme outcomes, however limited coverage of VL testing and acting on test results hampers its full potential. In our cohort children and adolescents, PLHIV with history of loss-to-follow-up or those with low-viremia are at the highest risk of virological failure and might require more frequent virological monitoring than is currently recommended.

Participants on dolutegravir re-suppress HIV RNA after virologic failure: updated data from the ADVANCE trial

2021 ◽  
Author(s):  
Toby Pepperrell ◽  
Willem Daniel Francois Venter ◽  
Kaitlyn McCann ◽  
Bronwyn Bosch ◽  
Melissa Tibbatts ◽  
...  
Keyword(s):  
Virological Failure ◽  
Virologic Failure ◽  
Hiv Rna ◽  
Suppressive Capacity

Abstract Following evidence of HIV RNA re-suppression on DTG-based regimens, we assess the re-suppressive capacity of ADVANCE participants on TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV. Viraemic participants were able to re-suppress within 3 follow-up visits of protocol-defined virological failure (PDVF) in 77/121(64%), 85/126(67%) and 44/138(32%) cases respectively (DTG regimens vs. TDF/FTC/EFV; p&lt;0.001).

scholarly journals 1021. HIV-1 RNA Blips and Low-Level Replication During Phase III/IIIb Cabotegravir + Rilpivirine Long-Acting Studies Are Similar to Oral 3-Drug Therapy and Not Associated with Week 48 Virologic Outcome

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S540-S541
Author(s):  
Christine L Talarico ◽  
Sterling Wu ◽  
Ojesh R Upadhyay ◽  
Marty St Clair ◽  
Veerle Van Eygen ◽  
...  
Keyword(s):  
Viral Load ◽  
Virologic Failure ◽  
Phase Iii ◽  
Individual Study ◽  
Treatment Groups ◽  
Qualitative And Quantitative ◽  
Low Level ◽  
Long Acting ◽  
Study Participants ◽  
Hiv 1

Abstract Background Phase III/IIIb studies demonstrated cabotegravir (CAB) + rilpivirine (RPV) long-acting (LA) dosed every 4 weeks (Q4W) was noninferior to current antiviral regimen (CAR) (FLAIR and ATLAS) and CAB + RPV LA dosed every 8 weeks (Q8W) was noninferior to Q4W (ATLAS-2M) through Week 48 (W48). HIV-1 ribonucleic acid (RNA) blips (viral load [VL] ≥50 to &lt; 200 c/mL) are common during antiretroviral therapy (ART) and generally not associated with subsequent virologic failure (2 consecutive HIV-1 RNA ≥200 c/mL). We compared the frequency of HIV-1 RNA blips and low-level qualitative and quantitative HIV-1 RNA replication among participants treated with CAB+RPV LA and oral CAR and assessed impact on virologic outcome. Methods Plasma samples collected at study visits were analyzed for HIV-1 RNA viral load using the Abbott RealTime HIV-1 assay and qualitative target detected (TD) or target not detected (TND) outcomes were provided for HIV-1 RNA &lt; 40 c/mL. The HIV-1 SuperLow assay (bioMONTR Labs) was used to measure HIV-1 RNA &lt; 2 c/mL at Baseline and W48. Results The proportion of participants with HIV-1 RNA blips was similar overall between Q4W CAB + RPV LA and CAR arms in FLAIR (38/283 [13%] vs 39/283 [14%]) and ATLAS (17/308 [6%] vs 23/308 [7%]). Presence of HIV-1 RNA blips in either arm was not associated with virologic non-response at W48 (HIV-1 RNA ≥50 c/mL per US Food and Drug Administration Snapshot). In ATLAS-2M, HIV-1 RNA blips were observed in 32/523 (6%; Q4W) and 18/522 (3%; Q8W) of participants, with W48 virologic nonresponse in 2 Q4W and 0 Q8W participants. TD outcomes at individual study visits were comparable between study arms for the 3 studies. At W48, the proportion of participants with HIV-1 RNA &lt; 2 c/mL was similar to Baseline and similar between treatment groups in all studies. Conclusion The proportions of study participants with HIV-1 RNA blips, TD viral load results, and HIV-1 &lt; 2 c/mL were similar between the Q4W and Q8W CAB+RPV LA and the oral 3-drug CAR arms through W48 in phase III/IIIb studies. HIV-1 RNA blips did not predict virologic nonresponse (Snapshot analysis) at W48. Disclosures Christine L. Talarico, M.S, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sterling Wu, PhD, GlaxoSmithKline (Employee, Shareholder) Marty St. Clair, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Veerle Van Eygen, MSc, Janssen Pharmaceutica NV (Employee) Krischan J. Hudson, PhD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Conn M. Harrington, BA, ViiV Healthcare (Employee) Jan van Lunzen, MD, PhD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder)

scholarly journals Long-Term Immunological and Virological Outcomes in Children Receiving Highly Active Antiretroviral Therapy at Hawassa University College of Medicine and Health Sciences, Southern Ethiopia

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Demissie Assegu Fenta ◽  
Temesgen Bizuayehu Wube ◽  
Metsihet Mohammed Nuru
Keyword(s):  
Viral Load ◽  
Virological Failure ◽  
Highly Active Antiretroviral Therapy ◽  
University Hospital ◽  
Rank Test ◽  
Southern Ethiopia ◽  
Viral Load Suppression ◽  
Highly Active ◽  
Hawassa University

Purpose. To determine immunological and virological failure and associated factors among children infected with human immunodeficiency virus receiving antiretroviral treatments at Hawassa University Hospital, Southern Ethiopia. Methods. A hospital-based cross-sectional study was conducted among 273 HIV-infected children from July 1 to December 1, 2019. Data were collected using a structured questionnaire and review of patient records. Blood samples for viral load and CD4 count were collected. Data were analyzed using SPSS version 20. Significance group comparison was done by the Kaplan-Meier log-rank test. The Cox proportional hazard model was used to select significant factors of the variability between groups. Results. A total of 273 children, between the age ranges of 1 to 14 years, were included. Of these, 139 (50.9%) and 134 (49.1%) were males and females, respectively. Children from the rural area were almost five times more vulnerable for virological and immunological failure than those children from the urban area ( AOR = 4.912 , (1.276-8.815), P = 0.032 ). The overall viral load suppression was 196 (71.8%) with a good adherence of 226 (82.9%). Nonsuppressed HIV viral load was found to be 77 (28.2%) which had two times more viral load copies ( AOR = 2.01 , (1.21–2.66), P = 0.001 ) when compared to those who had suppressed viral load copies. The proportions of children who had immunological nonresponse were 45.6% (21 out of 46), 30.4% (14 out of 46), and 23.9% (11 out of 46) among children with baseline CD4 of <200, 201-500, and >500 cells/μl, respectively. Unimproved outcomes among females were noted for immunological and virological failure in this study ( AOR = 1.901 , (1.038-3.481), P = 0.038 ). Conclusion. In conclusion, the highly active antiretroviral treatment appeared highly effective in terms of immunological and virological long-term outcomes. However, viral suppression (71.8%) in our study was far apart from the UNAIDS target of 90% in 2020. For that reason, strengthening adherence counseling and early initiation of HAART is important.

scholarly journals Faktor Prediktor Kegagalan Virologis pada Pasien HIV yang Mendapat Terapi ARV Lini Pertama dengan Kepatuhan Berobat Baik

2017 ◽  
Vol 4 (1) ◽  
pp. 29
Author(s):  
Farid Kurniawan ◽  
Samsuridjal Djauzi ◽  
Evy Yunihastuti ◽  
Pringgodigdo Nugroho
Keyword(s):  
Viral Load ◽  
Antiretroviral Therapy ◽  
Virological Failure ◽  
Clinical Stage ◽  
World Health ◽  
Weight Changes ◽  
First Line ◽  
Hiv Patients ◽  
Good Adherence ◽  
Study Results

Pendahuluan. Pada negara dengan keterbatasan sumber daya, pengukuran viral load (VL) sebagai prediktor efektivitas terapi antiretroviral (ARV) tidak selalu mudah untuk diakses oleh pasien HIV yang mendapat terapi ARV. Pada penelitian-penelitian sebelumnya, kepatuhan berobat (adherens) diketahui merupakan faktor penting terhadap supresi VL HIV. Penelitian ini bertujuan untuk mengetahui faktor prediktor kegagalan virologis pada pasien HIV yang mendapat terapi ARV lini pertama sesuai paduan ARV terbaru dengan kepatuhan berobat yang baik di Indonesia.Metode. Studi kohort retrospektif dilakukan pada pasien HIV rawat jalan dewasa di Rumah Sakit dr. Cipto Mangunkusumo (RSCM), Jakarta yang memulai terapi ARV lini pertama selama periode Januari 2011-Juni 2014. Pasien HIV dengan kepatuhan berobat baik yang mempunyai data VL 6-9 bulan setelah mulai terapi ARV dimasukkan sebagai subjek penelitian. Kegagalan virologis dinyatakan sebagai nilai VL ≥400 kopi/mL setelah minimal 6 bulan terapi ARV dengan kepatuhan berobat baik. Usia awal terapi ARV, faktor risiko penularan HIV, stadium klinis HIV menurut World Health Organization (WHO), koinfeksi HIV-TB, jumlah CD4 awal terapi, peningkatan jumlah CD4, kadar hemoglobin dan indeks massa tubuh awal terapi, perubahan berat badan selama terapi, dan basis paduan terapi ARV merupakan variabel yang diteliti pada penelitian ini.  Hasil. Terdapat 197 pasien sebagai subjek penelitian ini. Kegagalan virologis ditemukan pada 21 pasien (10,7%). Peningkatan CD4 <50 sel/mm3 setelah minimal 6 bulan terapi merupakan prediktor kegagalan virologis (p = 0,003; OR 5,802, 95% CI= 1,842-18,270). Terdapat peningkatan risiko kegagalan virologis pada pasien dengan terapi ARV berbasis NVP pada saat VL diperiksa, namun tidak bermakna secara statistik (p = 0,060; OR 2,756; 95% CI= 0,958-7,924). Simpulan. Peningkatan CD4 <50 sel/mm3 setelah minimal 6 bulan terapi dapat memprediksi kegagalan virologis pada pasien yang mendapat terapi ARV lini pertama dengan kepatuhan berobat yang baik. Kata Kunci: kegagalan virologis, terapi ARV lini pertama, viral load Predictors of Virological Failure in HIV Patients Receiving First Line Antiretroviral Therapy with Good AdherenceIntroduction. Antiretroviral therapy (ART) effectively suppress HIV replication. Viral load (VL) measurement is better predictor than clinical or immunological criteria to evaluate success or failure of ART. However, in country with limited resources, viral load measurement is not easily accessible by HIV patients receiving ART. Therefore, it is necessary to know which factors that can predict virological failure. In previous studies, adherence was an  important factor for suppression of HIV viral load.  This study is aimed to know predictors of virological failure in HIV patients receiving recent first line ART regimen with good adherence in Indonesia. Methods. A retrospective cohort study was conducted among adult HIV patients in Out-patient Clinic of Cipto Mangunkusumo Hospital that started ART during periode of  January 2011-June 2014. HIV patients with good adherence that had viral load data 6-9 months after initiation of ART were included in this study. Virological failure was defined as viral load ≥ 400 copies/mL after minimum of 6 months therapy with good adherence. Age at starting ART, risk factor for HIV infection, HIV clinical stage, HIV-TB co-infection, baseline CD4 value, CD4 count increase, baseline hemoglobin level and body mass index, weight changes during therapy, and ART based regimen were analyzed in this study. Results. A total of 197 patients were included in this study. Virological failure was found in 21 patients (10,7%). CD4 increase <50 cell/mm3 after minimum 6 months of ART was predictor of virological failure (p = 0,003; OR 5,802, 95%CI 1,842-18,270). Conclusion. CD4 increase <50 cell/mm3 after minimum 6 months therapy can predict virological failure in HIV patients receiving first line ART with good adherence.  

scholarly journals A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Farhan Raza Khan ◽  
Syed Murtaza Raza Kazmi ◽  
Najeeha Talat Iqbal ◽  
Junaid Iqbal ◽  
Syed Tariq Ali ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hydrogen Peroxide ◽  
Viral Load ◽  
Hypertonic Saline ◽  
Povidone Iodine ◽  
Nasal Lavage ◽  
Study Group ◽  
Neem Extract ◽  
Full Protocol ◽  
Randomised Controlled

Abstract Objectives 1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles. Trial design This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study. Participants A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus. Intervention and comparator Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes. Main outcomes The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR. Randomisation The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done. Blinding (masking) The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely. Numbers to be randomised (sample size) As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details. Trial Status Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021. Trial registration This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

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