Immediate versus deferred antiretroviral therapy in HIV-infected patients presenting with acute AIDS-defining events (toxoplasmosis, Pneumocystis jirovecii-pneumonia): a prospective, randomized, open-label multicenter study (IDEAL-study)

Abstract Background To evaluate clinical outcomes after either immediate or deferred initiation of antiretroviral therapy in HIV-1-infected patients, presenting late with pneumocystis pneumonia (PCP) or toxoplasma encephalitis (TE). Methods Phase IV, multicenter, prospective, randomized open-label clinical trial. Patients were randomized into an immediate therapy arm (starting antiretroviral therapy (ART) within 7 days after initiation of OI treatment) versus a deferred arm (starting ART after completing the OI-therapy). All patients were followed for 24 weeks. The rates of clinical progression (death, new or relapsing opportunistic infections (OI) and other grade 4 clinical endpoints) were compared, using a combined primary endpoint. Secondary endpoints were hospitalization rates after completion of OI treatment, incidence of immune reconstitution inflammatory syndrome (IRIS), virologic and immunological outcome, adherence to proteinase-inhibitor based antiretroviral therapy (ART) protocol and quality of life. Results 61 patients (11 patients suffering TE, 50 with PCP) were enrolled. No differences between the two therapy groups in all examined primary and secondary endpoints could be identified: immunological and virologic outcome was similar in both groups, there was no significant difference in the incidence of IRIS (11 and 10 cases), furthermore 9 events (combined endpoint of death, new/relapsing OI and grade 4 events) occurred in each group. Conclusions In summary, this study supports the notion that immediate initiation of ART with a ritonavir-boosted proteinase-inhibitor and two nucleoside reverse transcriptase inhibitors is safe and has no negative effects on incidence of disease progression or IRIS, nor on immunological and virologic outcomes or on quality of life.

Download Full-text

Dukungan sosial dan kualitas hidup orang dengan HIV/AIDS

Berita Kedokteran Masyarakat ◽

10.22146/bkm.12563 ◽

2017 ◽

Vol 33 (3) ◽

pp. 147

Author(s):

Mardia Mardia ◽

Riris Andono Ahmad ◽

Bambang Sigit Riyanto

Keyword(s):

Quality Of Life ◽

Social Support ◽

Antiretroviral Therapy ◽

Social Life ◽

Opportunistic Infections ◽

People Living With Hiv ◽

Hiv Diagnosis ◽

Criteria For Diagnosis ◽

Hiv Aids

Purpose: This study aimed to determine the quality of life among people living with HIV/AIDS based on the criteria for diagnosis and other factors.Methods: This study was conducted in the VCT clinic hospital of Dr. Moewardi. The population was HIV-positive patients with antiretroviral therapy. Data collection conducted through medical records and interview to patients. Results: Out of a total of 89 respondents, 66.29% were males and 71.91% were aged between 26-45 years. We found significant correlations for diagnosis of HIV/AIDS, opportunistic infections, time since HIV diagnosis, duration of ARV therapy, social support, modes of transport, sex, age, and marital status with the quality of life. Multivariate analysis obtained by each variable showed the strongest association with the quality of life was time since diagnosis, social support and duration of ARV therapy. Conclusion: The quality of life was better for those who have been diagnosed with HIV/AIDS ≥ 32 months, with social support, and who have been undergoing antiretroviral therapy ≥ 29 months. Improved counseling in the early days of ARV therapy is necessary to always maintain the treatment and provide support for their social life.

Download Full-text

Intra-Articular Hybrid Hyaluronic Acid Injection Treatment in Overweight Patients with Knee Osteoarthritis: A Single-Center, Open-Label, Prospective Study

Applied Sciences ◽

10.3390/app11188711 ◽

2021 ◽

Vol 11 (18) ◽

pp. 8711

Author(s):

Dalila Scaturro ◽

Fabio Vitagliani ◽

Pietro Terrana ◽

Daniele Cuntrera ◽

Vincenzo Falco ◽

...

Keyword(s):

Quality Of Life ◽

Hyaluronic Acid ◽

Knee Osteoarthritis ◽

Disease Severity ◽

Prospective Trial ◽

Open Label ◽

Knee Oa ◽

Symptomatic Knee ◽

Significant Difference

Background: A BMI > 25 is the most decisive, albeit modifiable, risk factor for knee osteoarthritis (KOA). This study aimed at assessing the efficacy of intra-articular injections of hybrid hyaluronic acid (HA) complexes (Sinovial® H-L) for the treatment of KOA in overweight patients in terms of disease severity, cardiocirculatory capacity, and quality of life. Materials: In this single-site, open-label, prospective trial, 37 patients with symptomatic knee OA were assessed at baseline and 3 months after ultrasound-guided intra-articular injection of hybrid HA complexes (Sinovial® H-L). Results: Primary variables displaying a statistically significant improvement after treatment were pain (VAS), disease severity (WOMAC), and cardiopulmonary capacity (6 min walk test). Among secondary variables, quality of life (SF-12) improved significantly, as did analgesic intake for pain control. No statistically significant difference was observed in body fat and muscle mass percentage measured by bioelectrical impedance analysis. Conclusions: Intra-articular hybrid HA injections are significantly effective in improving OA-related disease severity, cardiopulmonary function, and analgesic intake. This supports the role of hybrid HA viscosupplementation as a nonpharmacological treatment to relieve pain, reduce disability, improve quality of life, and limit the risk of polypharmacy in overweight patients with knee OA.

Download Full-text

Outcomes of AIDS-associated Kaposi sarcoma in Mozambique after treatment with pegylated liposomal doxorubicin

Infectious Agents and Cancer ◽

10.1186/s13027-020-00341-4 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Matthew E. Coldiron ◽

Ana Gabriela Gutierrez Zamudio ◽

Rolanda Manuel ◽

Gilda Luciano ◽

Barbara Rusch ◽

...

Keyword(s):

Quality Of Life ◽

Antiretroviral Therapy ◽

Liposomal Doxorubicin ◽

Pegylated Liposomal Doxorubicin ◽

Kaposi Sarcoma ◽

Disease Status ◽

Open Label ◽

Resource Setting

Abstract Background Kaposi’s sarcoma (KS) is a common HIV-associated malignancy frequently associated with poor outcomes. It is the most frequently diagnosed cancer in major cities of Mozambique. Antiretroviral therapy is the cornerstone of KS treatment, but many patients require cytotoxic chemotherapy. The traditional regimen in Mozambique includes conventional doxorubicin, bleomycin and vincristine, which is poorly tolerated. In 2016, pegylated liposomal doxorubicin was introduced at a specialized outpatient center in Maputo, Mozambique. Methods We performed a prospective, single-arm, open-label observational study to demonstrate the feasibility, safety, and outcomes of treatment with pegylated liposomal doxorubicin (PLD) in patients with AIDS-associated Kaposi sarcoma (KS) in a low-resource setting. Chemotherapy-naïve adults with AIDS-associated KS (T1 or T0 not responding to 6 months of antiretroviral therapy) were eligible if they were willing to follow up for 2 years. Patients with Karnofsky scores < 50 or contraindications to PLD were excluded. One hundred eighty-three patients were screened and 116 participants were enrolled. Patients received PLD on three-week cycles until meeting clinical stopping criteria. Follow-up visits monitored HIV status, KS disease, side effects of chemotherapy, mental health (PHQ-9) and quality of life (SF-12). Primary outcome measures included vital status and disease status at 6, 12, and 24 months after enrollment. Results At 24 months, 23 participants (20%) had died and 15 (13%) were lost to follow-up. Baseline CD4 < 100 was associated with death (HR 2.7, 95%CI [1.2–6.2], p = 0.016), as was T1S1 disease compared to T1S0 disease (HR 2.7, 95%CI [1.1–6.4], p = 0.023). Ninety-two participants achieved complete or partial remission at any point (overall response rate 80%), including 15 (13%) who achieved complete remission. PLD was well-tolerated, and the most common AEs were neutropenia and anemia. Quality of life improved rapidly after beginning PLD. Discussion PLD was safe, well-tolerated and effective as first-line treatment of KS in Mozambique. High mortality was likely due to advanced immunosuppression at presentation, underscoring the importance of earlier screening and referral for KS.

Download Full-text

Assessment of quality of life among HIV infected people on antiretroviral therapy in a tertiary hospital, Karnataka

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20211897 ◽

2021 ◽

Author(s):

Anjan Sreeranga ◽

P. Pavithra ◽

Anand D. Meundi

Keyword(s):

Quality Of Life ◽

Antiretroviral Therapy ◽

Rural Areas ◽

World Health ◽

Cross Sectional ◽

Infected People ◽

Significant Difference ◽

Patient Reported ◽

The Impact

Background: With the availability of highly effective antiretroviral treatment, HIV is transforming into a chronic condition, whose management is now experiencing problems of other chronic diseases, where quality of life (QOL) has become an important component of overall assessment of health care and management. This study was conducted with the objective of assessing the QOL and factors influencing it in HIV infected people on antiretroviral therapy (ART).Methods: A cross-sectional study was conducted at district ART center, Hassan. Purposive sampling was used to identify 148 HIV infected people on antiretroviral therapy, who were interviewed using a pretested questionnaire, assessing QOL with the World Health Organization (WHOQOL) HIV‑BREF.Results: The average age of the study population was 37.69 years. Majority of them were males 54.7% compared to 45.3% of females. Most of them resided in rural areas (87.8%). The educational status of the subjects was poor with 33.8% of them being illiterates. The mean score was highest for spirituality and social relationships domain and least for psychological domain. Age, education and socioeconomic status did not have any influence on the QOL. There was significant difference between QOL scores and clinical stages. Individuals in stage I and II had better scores compared to stage 3 and 4. QOL scores decreased with decreasing CD4 count.Conclusions: Our findings suggest that patient-reported measures of health status and related concepts may help provide a feasible, reliable and valid method to assess the impact of HIV/AIDS improve patient outcomes.

Download Full-text

The effect of concomitant fibromyalgia in HIV infected patients receiving antiretroviral therapy: a prospective cross-sectional study

Annals of Clinical Microbiology and Antimicrobials ◽

10.1186/s12941-019-0330-0 ◽

2019 ◽

Vol 18 (1) ◽

Author(s):

Umit Secil Demirdal ◽

Neriman Bilir ◽

Tuna Demirdal

Keyword(s):

Quality Of Life ◽

Antiretroviral Therapy ◽

T Lymphocyte ◽

Musculoskeletal System ◽

Lymphocyte Count ◽

Fibromyalgia Impact Questionnaire ◽

Cross Sectional ◽

Sf 36 ◽

Significant Difference

Abstract Background HIV infected patients receiving antiretroviral therapy (ART) have extensive musculoskeletal system involvement. Arthralgia and myalgia are the most common forms. Fibromyalgia Syndrome (FMS) is a chronic pain syndrome of the musculoskeletal system characterized by diffuse pain including arthralgia and myalgia. These overlapping symptoms are suggested the relationship between HIV and FMS. The primary purpose of this study was to determine the prevalence of FMS in HIV/AIDS patients. The secondary objective was to investigate the effects of FMS on functional status, depression, fatigue, sleep pattern and quality of life. Methods A total of 225 HIV infected patients who were receiving ART were included in this cross-sectional prospective study. The demographic data of the participants, CD4 T-lymphocyte count (cells/mm3), viral load (> 40 copy/ml), and ART regimens were recorded. FMS diagnosis was based on 2016 revision of diagnostic criteria. All patients completed the following questionnaires: Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and SF-36 scale. Results FMS was found in 20% of the HIV infected patients (n = 45). The mean duration of disease was 4.74 ± 4.42 years; it was significantly longer in patients with FMS (p = 0.007). The median CD4 T-lymphocyte count was found to be 616.00 ± 303.91 cells/mm3, and it was significantly higher in patients without FMS (p = 0.06). No statistically significant difference was found between the two groups according to the drug regimens used. A statistically significant difference was found in FIQ, BDI, PSQI, FSS and all subgroups of the SF-36 scale between the patients with and without FMS (p = 0.001). Conclusions A slightly higher frequency of FMS was determined in HIV infected patients receiving ART compared to previous studies. It was shown that presence of FMS negatively affected the function, depression, fatigue, sleep, and quality of life. Detection of FMS may decrease depression, fatigue, and sleep disorders and increase the quality of life in HIV infected patients. FMS should be distinguished correctly for an accurate treatment management of HIV and for increasing ART compliance.

Download Full-text

Complete withdrawal is the most effective approach to reduce disability in patients with medication-overuse headache: A randomized controlled open-label trial

Cephalalgia ◽

10.1177/0333102419828994 ◽

2019 ◽

Vol 39 (7) ◽

pp. 863-872 ◽

Cited By ~ 8

Author(s):

Mia Nielsen ◽

Louise Ninett Carlsen ◽

Signe Bruun Munksgaard ◽

Ida Maria Storm Engelstoft ◽

Rigmor Højland Jensen ◽

...

Keyword(s):

Quality Of Life ◽

Medication Overuse ◽

Medication Overuse Headache ◽

Tension Type Headache ◽

Response To Treatment ◽

Open Label ◽

Significant Difference ◽

Headache Patients

Background Medication-overuse headache leads to high disability and decreased quality of life, and the best approach for withdrawal has been debated. Aim To compare change in disability and quality of life between two withdrawal programs. Methods We randomized medication-overuse headache patients to program A (two months without acute analgesics or migraine medications) or program B (two months with acute medications restricted to two days/week) in a prospective, outpatient study. At 6 and 12 months, we measured disability and headache burden by the Headache Under-Response to Treatment index (HURT). We estimated quality of life by EUROHIS-QOL 8-item at 2-, 6-, and 12-month follow-up. Primary endpoint was disability change at 12 months. Results We included 72 medication-overuse headache patients with primary migraine and/or tension-type headache. Fifty nine completed withdrawal and 54 completed 12-month follow-up. At 12-month follow-up, 41 patients completed HURT and 38 completed EUROHIS-QOL 8-item. Disability reduction was 25% in program-A and 7% in program-B ( p = 0.027). Headache-burden reduction was 33% in program-A and 3% in program-B ( p = 0.005). Quality of life was increased by 8% in both programs without significant difference between the programs ( p = 0.30). At 2-month follow-up, quality of life increased significantly more in program-A than program-B ( p = 0.006). Conclusion Both withdrawal programs reduced disability and increased quality of life. Withdrawal without acute medication was the most effective in reducing disability in medication-overuse headache patients. Trial registration Clinicaltrials.gov (NCT02903329).

Download Full-text

An Open-Label, Randomized Trial of Methylphenidate and Atomoxetine Treatment in Adults With ADHD

Journal of Attention Disorders ◽

10.1177/1087054713476549 ◽

2016 ◽

Vol 21 (1) ◽

pp. 27-39 ◽

Cited By ~ 13

Author(s):

Hsing-Chang Ni ◽

Yu-Ju Lin ◽

Susan Shur-Fen Gau ◽

Hui-Chun Huang ◽

Li-Kuang Yang

Keyword(s):

Quality Of Life ◽

Immediate Release ◽

Functional Impairments ◽

Open Label ◽

Social Functions ◽

Significant Group ◽

Once Daily ◽

Ethnic Chinese ◽

Significant Difference

Objective: To directly compare the efficacy of methylphenidate and atomoxetine in improving symptoms, social functions, and quality of life among adults with ADHD. Method: This was an 8-to-10-week, open-label, head-to-head, randomized clinical trial with two treatment arms: immediate-release methylphenidate (IR-methylphenidate; n = 31) and atomoxetine once daily ( n = 32). The outcome measures included ADHD symptom severity, quality of life, and functional impairments. Results: We found a significant reduction in overall ADHD symptoms and improvement in social functions and quality of life for both groups at Weeks 4 to 5 and Weeks 8 to 10. There was no significant difference in the slope of improvements over time except that atomoxetine was superior to IR-methylphenidate in reducing hyperactive/impulsive symptoms at Weeks 4 to 5. There was no significant group difference in the rates of adverse effects. Conclusion: Both IR-methylphenidate and atomoxetine are well tolerated and efficacious in ethnic Chinese adults with ADHD.

Download Full-text

OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program

Cephalalgia ◽

10.1177/0333102416652092 ◽

2016 ◽

Vol 36 (9) ◽

pp. 899-908 ◽

Cited By ~ 46

Author(s):

Richard B Lipton ◽

Noah L Rosen ◽

Jessica Ailani ◽

Ronald E DeGryse ◽

Patrick J Gillard ◽

...

Keyword(s):

Quality Of Life ◽

Chronic Migraine ◽

Life Questionnaire ◽

Open Label ◽

Double Blind ◽

Significant Difference ◽

Related Quality ◽

Prophylaxis Therapy ◽

Clinical Trial Program

Background Chronic migraine (CM) is associated with high impact and reduced health-related quality of life (HRQoL). Methods Patients with CM from PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) were randomized (1:1) to receive onabotulinumtoxinA or placebo for two 12-week cycles in the double-blind (DB) phase, followed by three 12-week cycles of open-label (OL) onabotulinumtoxinA (onabotulinumtoxinA/onabotulinumtoxinA (O/O) and placebo/onabotulinumtoxinA (P/O) groups, respectively). HRQoL endpoints were assessed over 56 weeks using the Headache Impact Test (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ). HIT-6 score reductions ≥2.3 and ≥5 denoted between-group minimally important difference and within-patient clinically meaningful response, respectively. Results A total of 1236 participants (O/O, n = 607; P/O, n = 629) participated in both phases. The DB phase showed significantly reduced HIT-6 and MSQ for onabotulinumtoxinA versus placebo (all p < 0.001). The OL phase showed significantly reduced HIT-6 for O/O versus P/O at weeks 28, 36, and 48, but not 56. All three MSQ domains showed improved HRQoL relative to baseline, but only the role restrictive domain showed a significant difference between O/O and P/O at week 56. Conclusions Benefits of onabotulinumtoxinA on HRQoL versus baseline persisted throughout the OL phase. Statistical superiority in favor of O/O was demonstrated for HIT-6 through 48 weeks and for MSQ (role restrictive) at 56 weeks.

Download Full-text

Multidimensional Quality of Life of HIV/AIDS Patients Who Undergo ARV Therapy in Maccini Clinic Makassar

KnE Life Sciences ◽

10.18502/kls.v4i13.5235 ◽

2019 ◽

Author(s):

Muh Yusuf Tahir

Keyword(s):

Quality Of Life ◽

Immune System ◽

Antiretroviral Therapy ◽

Hiv Infection ◽

Incubation Period ◽

Opportunistic Infections ◽

Inclusion Criteria ◽

Aids Patients ◽

Hiv Aids

Background: AIDS is a collection of symptoms caused by a variety of microorganisms and other ferocity due to the decreased resistance/immunity of the patient.GlobalAIDS epidemicshowsthatthereare34millionpeoplewithHIVworldwide.InSoutheastAsia, there are approximately 4 million people with HIV. HIV infection in humans has a long incubation period (5-10 years), and then the patient can be called as people living with HIVHIVcausesimmunedeﬁciencysothatthepatientsarevulnerabletoopportunistic infection attack. Antiretroviral (ARV) could be given the patients to stop a virus and restoring the immune system, reduce the occurrence of opportunistic infections, improve the quality of life and decrease disability. Objectives: This study aims to explore the Multidimensional Quality of Life of HIV/AIDS patients in Maccini Clinic Makassar. Methods:Phenomenological study conducted to explore the experiences of informants related to the quality of life of HIV/AIDS patients who have antiretroviral therapy. Ten informants selected based on inclusion criteria using purposive sampling. Data were collected through interviews and analysis with the aid of N Vivo software version 10. Results: The results of this study shows that after having antiretroviral therapy, HIV/AIDS patients have increased in physical, psychological, social, functional, environmental, spiritual, and sexual dimensions. Conclusions: The dimension that gives most inreasing of the quality of life in HIV patients was physical dimension.

Download Full-text