scholarly journals Pharmacokinetics of Two Multiple-Dosing Regimens of D0870 in Human Immunodeficiency Virus-Positive Patients: a Phase I Study

1998 ◽  
Vol 42 (4) ◽  
pp. 903-906 ◽  
Author(s):  
S. De Wit ◽  
E. O’Doherty ◽  
J. Edwards ◽  
R. Yates ◽  
R. P. Smith ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Adverse Events ◽  
Hiv Positive ◽  
Loading Dose ◽  
Dosing Regimen ◽  
Accumulation Ratio ◽  
Once Daily ◽  
Immunodeficiency Virus ◽  
Dosing Regimens ◽  
Oral Doses

ABSTRACT D0870 is a triazole with a broad antifungal spectrum, and it has been shown to have both in vitro and in vivo activities against wild-type and fluconazole-resistant strains of Candida albicans. Twenty-two human immunodeficiency virus (HIV)-positive male subjects were enrolled in an open, nonrandomized trial investigating the pharmacokinetics of two different dosing regimens of D0870 and assessing the safety of multiple oral doses of D0870 in HIV-positive subjects and their ability to tolerate multiple oral doses. Nine subjects received an initial loading dose of 50 mg, followed by four once-daily maintenance doses of 10 mg. A further nine subjects received an initial 200-mg loading dose followed by four daily maintenance doses of 25 mg. All subjects were fasting. A single loading dose of 50 mg of D0870 resulted in a mean maximum concentration in serum (C max) of 107 ± 32 ng/ml. Concentrations in plasma were maintained by the 10-mg once-daily dosing regimen as seen by the similar values of the area under the concentration-time curve from 0 to 24 h following dosing on days 1 and 5 and a mean accumulation ratio close to unity (0.90). The terminal plasma half-life of D0870 in plasma following dosing on day 5 ranged from 23 to 85 h (mean, 49 h). A single loading dose of 200 mg of D0870 resulted in a C max of 431 ± 186 ng/ml. Concentrations in plasma were again maintained by the 25-mg daily dosing regimen, with the mean accumulation ratio being close to unity (1.17). The terminal half-life of D0870 in plasma following dosing on day 5 of phase II of the study ranged from 34 to 137 h (mean, 71 h). In addition, the concentrations achieved in the plasma of these HIV-positive subjects were similar to the values predicted from simulations based on data derived from normal, healthy subjects. D0870 was well tolerated. No serious adverse events were experienced during the course of the study, and all volunteers completed the trial. A total of 15 adverse events were reported, but none were considered to be related to the administration of D0870 and all had resolved by the end of the trial. No changes in the hematology, clinical chemistry, or urinalysis parameters were considered to be related to dosing with D0870. No clinically significant changes in the electrocardiogram parameters were noted during the trial. The data generated in this trial support further investigation of these regimens with HIV-positive subjects with fluconazole-susceptible or -resistant oropharyngeal candidosis.

scholarly journals A Randomized Controlled Trial of Isoniazid to Prevent Mycobacterium tuberculosis Infection in Kenyan Human Immunodeficiency Virus–Exposed Uninfected Infants

2020 ◽  
Author(s):  
Sylvia M LaCourse ◽  
Barbra A Richardson ◽  
John Kinuthia ◽  
A J Warr ◽  
Elizabeth Maleche-Obimbo ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Mycobacterium Tuberculosis ◽  
High Risk ◽  
Adverse Events ◽  
Controlled Trial ◽  
Preventive Therapy ◽  
Infection Prevalence ◽  
Mycobacterium Tuberculosis Infection ◽  
Immunodeficiency Virus ◽  
Exposed Uninfected

Abstract Background Human immunodeficiency virus (HIV)–exposed uninfected (HEU) infants in endemic settings are at high risk of tuberculosis (TB). For infants, progression from primary Mycobacterium tuberculosis (Mtb) infection to TB disease can be rapid. We assessed whether isoniazid (INH) prevents primary Mtb infection. Methods We conducted a randomized nonblinded controlled trial enrolling HEU infants 6 weeks of age without known TB exposure in Kenya. Participants were randomized (1:1) to 12 months of daily INH (10 mg/kg) vs no INH. Primary endpoint was Mtb infection at end of 12 months, assessed by interferon-γ release assay (QuantiFERON-TB Gold Plus) and/or tuberculin skin test (TST, added 6 months after first participant exit). Results Between 15 August 2016 and 6 June 2018, 416 infants were screened, with 300 (72%) randomized to INH or no INH (150 per arm); 2 were excluded due to HIV infection. Among 298 randomized HEU infants, 12-month retention was 96.3% (287/298), and 88.9% (265/298) had primary outcome data. Mtb infection prevalence at 12-month follow-up was 10.6% (28/265); 7.6% (10/132) in the INH arm and 13.5% (18/133) in the no INH arm (7.0 vs 13.4 per 100 person-years; hazard ratio, 0.53 [95% confidence interval {CI}, .24–1.14]; P = .11]), and driven primarily by TST positivity (8.6% [8/93] in INH and 18.1% [17/94] in no INH; relative risk, 0.48 [95% CI, .22–1.05]; P = .07). Frequency of severe adverse events was similar between arms (INH, 14.0% [21/150] vs no INH, 10.7% [16/150]; P = .38), with no INH-related adverse events. Conclusions Further studies evaluating TB preventive therapy to prevent or delay primary Mtb infection in HEU and other high-risk infants are warranted. Clinical Trials Registration NCT02613169.

scholarly journals SAT0078 SAFETY OF LOW DOSE METHOTREXATE (MTX) IN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 974.2-974
Author(s):  
A. Gunay ◽  
A. Davidson ◽  
I. Colmegna ◽  
D. Lacaille ◽  
H. Loewen ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Adverse Events ◽  
Low Dose ◽  
Opportunistic Infections ◽  
Case Reports ◽  
Cross Sectional Study ◽  
Study Quality ◽  
Sectional Study ◽  
Cross Sectional ◽  
Immunodeficiency Virus

Background:Increased awareness of the efficacy of MTX in rheumatic disease is leading to more MTX use in patients from HIV endemic areas. While HIV related immunosuppression may contribute to improvement of some rheumatic diseases, immune reconstitution from highly active antiretroviral therapy (HAART) may lead to exacerbation or presentation of autoimmune disorders for which MTX therapy may be warranted. Most management guidelines for rheumatic disease do not address MTX use in the context of HIV.Objectives:To systematically review the published literature on the safety of using MTX ≤30 mg per week in HIV.Methods:We searched CINAHL, Embase, Global, MEDLINE and World of Science databases (Jan 1990 to May 2018) for terms including ‘methotrexate’ and ‘human immunodeficiency virus’. We also searched citations from review articles. Titles, abstracts or full manuscripts were screened independently by 2 reviewers to identify studies reporting HIV in patients taking MTX. Study quality was assessed using the McGill Mixed Methods Appraisal Tool (MMAT). Data was extracted on MTX and HIV adverse events (MTX toxicity, HIV viral load, CD4 count). Descriptive summaries are presented for studies providing outcomes in patients taking MTX ≤30 mg per week.Results:After removing duplicates and studies not meeting criteria or not providing sufficient information, 42 of the 2714 identified reports were included (1 clinical trial, 2 cohort, 1 cross-sectional study, 38 case reports/case series). Most reports (81%) originated from USA or Europe. Study quality was generally good with most studies fulfilling 50-100% of MMAT criteria. The randomized controlled trial (USA) assessing MTX on atherosclerotic disease in HIV showed that adverse events were more common in MTX versus placebo (12.8% vs 5.6%, p non-inferiority <0.05) and included infection, transient CD4 and CD8 drop, pulmonary toxicity, and death (1 attributed to MTX/HIV, 1 unrelated). One cohort study (South Africa) reported 43 RA patients on MTX who acquired HIV. In this cohort, RA generally improved despite only 5 individuals continuing MTX. No data on MTX adverse event rates was reported. One cohort study (USA) reported 13 HIV patients with myositis. One received MTX (with other immunosuppression) without MTX adverse effects but died due to AIDS. A cross-sectional study (France) of 43 HIV pts with autoimmune disease reported one patient on MTX (and other immunosuppression) developed an adverse event (cytopenia) compared to 5/33 patients not on MTX (cytopenia). The 38 case reports/series described 54 individuals with HIV receiving MTX. Of these studies, 27 (describing 42 subjects) reported on MTX adverse events and 35 (describing 46 subjects) reported on HIV adverse events. MTX adverse events developed in 29 subjects (hematologic 13, renal/hepatic 1, opportunistic infections 10, other events 2). HIV adverse events were noted in 23 subjects (Kaposi’s sarcoma 4, CD4 decrease 16, HIV viral titer increase 4). Five deaths were reported (2 infection, 1 infection and wasting, 2 HIV related deaths). Most subjects also received corticosteroids or other immunosuppressants including biologics.Conclusion:There remains limited data on the safety of low dose MTX in HIV. Surveillance for HIV is warranted for individuals on MTX who are at risk for acquiring HIV. Caution and careful monitoring for MTX toxicity, opportunistic infections and HIV state is suggested if MTX is used in the setting of HIV particularly if combined with other immunosuppression.References:[1] Clin Infectious Disease 2019:68[2] J Rheumatology 2014:41[3] Arthritis and Rheumatism 2003:49[4] Medicine 2017:96Acknowledgments :Funding from International League Against RheumatismMcGill University Global Health Scholar AwardsDisclosure of Interests:Alize Gunay: None declared, Anna Davidson: None declared, Ines Colmegna: None declared, Diane Lacaille: None declared, Hal Loewen: None declared, Michele Meltzer: None declared, Yewondwossen Mengistu: None declared, Rosie Scuccimarri: None declared, Zenebe Yirsaw: None declared, Sasha Bernatsky: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada

scholarly journals Influence of boarding secondary school environment on HIV positive students in South Western Uganda

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Raymond Bernard Kihumuro ◽  
David Jolly Muganzi ◽  
Elton George Wandira ◽  
Racheal Alinaiswe ◽  
Jovitah Joselyne Nanyunja ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Secondary School ◽  
Secondary Schools ◽  
School Environment ◽  
Coping Mechanisms ◽  
Hiv Positive ◽  
Key Informants ◽  
Immunodeficiency Virus ◽  
Negative Coping ◽  
Depth Interviews

Abstract Background The number of human immunodeficiency virus (HIV) positive adolescents in secondary school has increased over the years. Little is known on how the students cope to the pressures and demands of their academic and health lives in the boarding secondary schools. This study explored the factors surrounding their anti-retroviral therapy adherence as well as their experiences. Methods We did a qualitative study that employed in-depth interviews amongst purposively selected 19 HIV positive adolescent students in boarding secondary school and seven key informants. Key informants were members of boarding secondary school staff directly taking care of the adolescents living with human immune virus and had spent at least two academic terms in that school. The study participants were recruited from four health facilities in Bushenyi district, southwestern Uganda, and key informants from five boarding secondary schools in Bushenyi. These were engaged in in-depth interviews using an interview guide. Data was transcribed, coded and the content analyzed thematically. Results Adolescents living with human immunodeficiency virus in boarding secondary school face challenges similar to adolescents outside boarding school settings. However, some challenges are unique to them. Students faced numerous barriers which made it difficult to adhere to their medication. Stigmatization in its different forms was also a major challenge amongst students. Willingness disclosure of serostatus was beneficial to the students since it guaranteed support while at school; facilitating adherence and better living. However, students were uneasy to disclose their status. Some students adopted negative coping mechanisms such as telling lies, escaping from school, and class to access medication. Conclusions Adolescents in boarding secondary schools face similar challenges as compared to their counterparts with some being unique to them. Few school mechanisms help these students to cope while at school. Limited disclosure has proven useful but some adolescents have opted not to disclose their status and hence used negative coping mechanisms. These challenges need to be addressed and a safe environment to encourage limited disclosure should be made.

Pneumocystis carinii infection in bilateral aural polyps in a human immunodeficiency virus-positive patient

2002 ◽  
Vol 116 (4) ◽  
pp. 288-290 ◽  
Author(s):  
C. V. Praveen ◽  
R. M. Terry ◽  
M. Elmahallawy ◽  
C. Horsfield
Keyword(s):  
Human Immunodeficiency Virus ◽  
Opportunistic Infection ◽  
Pneumocystis Carinii ◽  
Lymphatic Vessels ◽  
Blood Stream ◽  
Positive Patient ◽  
Hiv Positive ◽  
Immunodeficiency Virus ◽  
History Of ◽  
Pneumocystis Carinii Infection

Pneumocystis carinii is an opportunistic infection found in patients with impaired immunity. Under favourable conditions the parasite can spread via the blood stream or lymphatic vessels and cause extrapulmonary dissemination. We report a case of P carinii infection presenting as bilateral aural polyps, otitis media and mastoiditis in human immunodeficiency (HIV)-positive patient with no history of prior or concomitant P carinii infection.

Abstract WP426: Subarachnoid Hemorrhage in patients infected with Human Immunodeficiency Virus

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Haralabos Zacharatos ◽  
Malik M Adil ◽  
Ameer E Hassan ◽  
Sarwat I Gilani ◽  
Adnan I Qureshi
Keyword(s):  
Human Immunodeficiency Virus ◽  
Subarachnoid Hemorrhage ◽  
Blood Transfusion ◽  
Hospital Mortality ◽  
Hiv Infection ◽  
The United States ◽  
Hiv Positive ◽  
Published Data ◽  
Immunodeficiency Virus ◽  
Hiv Negative

Background: There is limited data regarding the unique attributes of ischemic stroke among patients infected with human immunodeficiency virus (HIV). There is no published data regarding the occurrence and outcomes of subarachnoid hemorrhage (SAH) among HIV infected persons. Methods: The largest all-payer Nationwide Inpatient Sample (NIS 2002-2010) data was used to identify and analyze all patients presenting with the primary diagnosis of SAH in the United States. Among this cohort, we identified the patients who were not HIV positive and those who were HIV positive. Patient demographics, medical co-morbidities, in-hospital complications, in-hospital procedures, and discharge disposition were compared between the two groups. The association between HIV infection and outcomes was evaluated in multivariate analysis after adjusting for potential confounders. Results: Of the 351,491 patients admitted with SAH, 1367 (0.39%) were infected with HIV. HIV infected patients were younger, mean age [±SD] of 45 ±14.2 years versus those who were not 58±19 years, (p<0.0001). The rate of blood transfusion [27,286 (7.8%) versus 245.6 (18%), p=0.0003], mechanical ventilation [51,199 (14.6%) versus 316.1(23.1%), p=0.008], and sepsis [14,644 (4.2%) versus 236.1 (17.3%), p<0.0001] was significantly higher among HIV infected patients. After adjusting for age, gender, hypertension, coagulopathy, atrial fibrillation, renal failure, and dyslipidemia, HIV negative patients had a significantly higher rate of discharge to home (odds ratio [OR] 1.9, 95% CI: 1.4-2.6, p<0.0001) and lower in-patient mortality (OR 0.4, 95% CI: 0.3-0.5, p<0.001). Further adjustment for blood transfusion and sepsis reduced the odds of discharge to home for the HIV negative patients, from 1.9 to 1.7 but did not affect in-hospital mortality. Conclusion: The in-hospital mortality in HIV infected patients with SAH is higher despite these patients being younger than non-HIV infected patients. We believe that this study provides a nationwide perspective which may have some important implications for early recognition and diagnosis of HIV-infection in SAH patients.

Antimalarial drug resistance markers in human immunodeficiency virus (HIV)-positive and HIV-negative adults with asymptomatic malaria infections in Port Harcourt, Nigeria

2021 ◽  
Author(s):  
Ifeyinwa Chijioke-Nwauche ◽  
Mary C Oguike ◽  
Chijioke A Nwauche ◽  
Khalid B Beshir ◽  
Colin J Sutherland
Keyword(s):  
Human Immunodeficiency Virus ◽  
Drug Resistance ◽  
Drug Susceptibility ◽  
Blood Film ◽  
University Hospital ◽  
Hiv Positive ◽  
Asymptomatic Malaria ◽  
Immunodeficiency Virus ◽  
Before And After ◽  
Hiv Negative

Abstract Background In Nigeria, indiscriminate use of antimalarial drugs may contribute to the threat of drug resistance, but this has not been evaluated among people living with human immunodeficiency virus (HIV). Methods HIV-positive adults attending a university hospital HIV clinic and HIV-negative adult volunteers from the university hospital community with a positive blood film were treated with artemether–lumefantrine. Parasite DNA from before and after treatment was polymerase chain reaction amplified to identify molecular markers of drug susceptibility. Results The pfcrt76T genotype was prevalent among both HIV-positive and HIV-negative participants (78.6% and 68.2%, respectively). Three new mutations in the pfmdr1 gene—F73S, S97L and G165R—and the uncommon pfdhps S436F variant were detected, whereas pfdhps K540E and pfdhfr I164L were absent. The A437G allele of pfdhps predominated (62/66 [94%]). The I431 V mutation was found in 19 of 66 pretreatment pfdhps sequences (28.8%). The pfmdr1 86N allele was significantly more common at day 3 post-treatment than at baseline (odds ratio 8.77 [95% confidence interval 1.21 to 380]). Conclusions We found evidence of continued chloroquine use among HIV-positive individuals. Selection for the pfmdr1 86N after artemether–lumefantrine treatment was observed, indicating a possible threat to antimalarial efficacy in the study area. The complexity of pfdhps haplotypes emphasises the need for careful monitoring of anti-folate susceptibility in Nigeria.

scholarly journals A High Prevalence Rate of a Positive Screen for Cognitive Impairment in Patients With Human Immunodeficiency Virus Attending an Irish Clinic

2016 ◽  
Vol 4 (1) ◽  
Author(s):  
Patricia H. McNamara ◽  
Robert Coen ◽  
Janice Redmond ◽  
Colin P. Doherty ◽  
Colm Bergin
Keyword(s):  
Human Immunodeficiency Virus ◽  
Cognitive Impairment ◽  
Large Scale ◽  
Screening Program ◽  
Cross Sectional Study ◽  
Hiv Positive ◽  
Study Cohort ◽  
Cross Sectional ◽  
Positive Screen ◽  
Immunodeficiency Virus

Abstract Background Human immunodeficiency virus (HIV)-associated neurocognitive disorders occurs in 20%–50% of HIV-positive patients. We undertook this study to assess the prevalence of a positive screen for cognitive impairment in the clinic population at our institution and to demonstrate the feasibility of implementing a screening program in routine clinical encounters. Methods This was a cross-sectional study, and patients were recruited prospectively between December 2010 and February 2013. Inclusion criteria were as follows: patients were HIV positive, over the age of 18, capable of giving informed consent, and had sufficient ability to communicate in English. Patients were screened for cognitive impairment using the Brief Neurocognitive Screen. Results A total of 604 patients were recruited, and 51.5% had a positive screen for cognitive impairment. The majority of the study cohort were male (78.8%), mean age was 40.9 (standard deviation, 10.2) years, 70.9% were Irish, the most common mode of transmission was men who have sex with men (49.3%), 83% were on antiretroviral therapy, and 88.7% were virally suppressed. Logistic regression showed that the main factors predictive of a positive screen for cognitive impairment were the endorsement of cognitive symptoms (P = .024), being born in Africa (P &lt; .000001), the use of benzodiazepines (P = .00341), being unemployed (P = .008), and consumption of more than 40 units of alcohol weekly (P = .035). There was a positive screen for depression in 9.1% and a positive screen for anxiety in 24.5%. Conclusions The study highlights the necessity for a structured, prospective, large-scale screening program for cognitive impairment across countries with limited resources and demonstrates the feasibility of easily implementing this with minimal training.

scholarly journals Impact of Next-generation Sequencing Defined Human Immunodeficiency Virus Pretreatment Drug Resistance on Virological Outcomes in the ANRS 12249 Treatment-as-Prevention Trial

2018 ◽  
Vol 69 (2) ◽  
pp. 207-214 ◽  
Author(s):  
Anne Derache ◽  
Collins C Iwuji ◽  
Kathy Baisley ◽  
Siva Danaviah ◽  
Anne-Geneviève Marcelin ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Clinical Trials ◽  
Transcriptase Inhibitor ◽  
Hiv Positive ◽  
Treatment As Prevention ◽  
Kwazulu Natal ◽  
Immunodeficiency Virus ◽  
Virological Outcomes ◽  
Reverse Transcriptase Inhibitor ◽  
Generation Sequencing

Abstract Background Previous studies in human immunodeficiency virus (HIV)-positive individuals on thymidine analogue backbone antiretroviral therapy (ART) with either nevirapine or efavirenz have suggested poorer virological outcomes in the presence of pretreatment drug resistance (PDR). We assessed the impact of PDR on virological suppression (VS; <50 copies/mL) in individuals prescribed primarily tenofovir/emtricitabine/efavirenz in rural KwaZulu-Natal within a treatment-as-prevention trial. Methods Among 1557 HIV-positive individuals who reported no prior ART at study entry and provided plasma samples, 1328 individuals with entry viral load (VL) >1000 copies/mL had next-generation sequencing (NGS) of the HIV pol gene with MiSeq technology. Results were obtained for 1148 individuals, and the presence of PDR was assessed at 5% and 20% detection thresholds. Virological outcome was assessed using Cox regression in 837 of 920 ART initiators with at least 1 follow-up VL after ART initiation. Results PDR prevalence was 9.5% (109/1148) and 12.8% (147/1148) at 20% and 5% thresholds, respectively. After a median of 1.36 years (interquartile range, 0.91–2.13), mostly on fixed-dose combination tenofovir/emtricitabine/efavirenz, presence of both nonnucleoside reverse transcriptase inhibitor (NNRTI)/nucleoside reverse transcriptase inhibitor PDR vs no PDR was associated with longer time to VS (adjusted hazard ratio [aHR], 0.32; 95% confidence interval [CI], 0.12–0.86), while there was no difference between those with only NNRTI PDR vs no PDR (aHR, 1.05; 95% CI, 0.82–1.34) at the 5% threshold. Similar differences were observed for mutations detected at the 20% threshold, although without statistical significance. Conclusions NGS uncovered a high prevalence of PDR among participants enrolled in trial clinics in rural KwaZulu-Natal. Dual-class PDR to a mainly tenofovir/emtricitabine/efavirenz regimen was associated with poorer VS. However, there was no impact of NNRTI PDR alone. Clinical Trials Tegistration NCT01509508; South African National Clinical Trials Register: DOH-27-0512-3974.

scholarly journals Pharmacologic Characteristics of Indinavir, Didanosine, and Stavudine in Human Immunodeficiency Virus-Infected Children Receiving Combination Therapy

2000 ◽  
Vol 44 (4) ◽  
pp. 1029-1034 ◽  
Author(s):  
Courtney V. Fletcher ◽  
Richard C. Brundage ◽  
Rory P. Remmel ◽  
Linda M. Page ◽  
Dennis Weller ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Trough Concentration ◽  
Area Under The Curve ◽  
Hiv Protease ◽  
Pharmacokinetic Parameters ◽  
Hiv Protease Inhibitors ◽  
Hiv Rna ◽  
Immunodeficiency Virus ◽  
Dosing Regimens ◽  
Outcomes For Children

ABSTRACT The use of human immunodeficiency virus (HIV) protease inhibitors in children has lagged behind that in adults because of the lack of suitable pediatric formulations and information on safe and effective dosing regimens. This study was designed to obtain pharmacokinetic information on indinavir, administered to HIV-infected children also receiving therapy with two nucleoside agents, and to explore relationships between pharmacokinetic parameters and anti-HIV effect. Indinavir was initiated at a dose of 500 mg/m2 every 8 h. Plasma indinavir concentrations were measured every 4 weeks; the dose or dosing interval was adjusted to maintain trough concentrations of ≥0.1 mg/liter. All children were evaluated clinically at baseline and every 4 weeks. Plasma HIV RNA was quantitated at baseline and at weeks 4, 12, and 24. Eighteen children participated in this study. The average daily dose of indinavir was 2,043 mg/m2; nine children received indinavir at 6-h intervals. Pharmacokinetic characteristics of indinavir (mean ± standard deviation) were the following: oral clearance, 1.4 ± 0.5 liters/h/kg; half-life, 1.1 ± 0.43 h; and trough concentration, 0.29 ± 0.32 mg/liter. In nine children that completed 24 weeks of therapy, the baseline-to-week-24 change in HIV RNA level was related to indinavir trough concentration and didanosine area under the curve. This study illustrates the ability to obtain pharmacokinetic information from children during routine clinic visits and to use this information to provide a safeguard against underdosing. The incorporation of pharmacologic knowledge with virologic, immunologic, and behavioral considerations should result in improved clinical outcomes for children infected with HIV.

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