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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT02395289 Completed - Clinical trials for Human Immunodeficiency Virus

Cognitive-Based Compassion Training (CBCT) for People Living With HIV (PLHIV)

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to examine the effects of cognitive-based compassion training (CBCT), a meditative practice based on Buddhist teachings, on long term emotional well-being and immune system improvement with people living with Human Immunodeficiency Virus (PLHIV).

NCT ID: NCT02390310 Completed - Clinical trials for Human Immunodeficiency Virus

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

Start date: May 2015
Phase: N/A
Study type: Interventional

This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases: Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa. Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.

NCT ID: NCT02358226 Completed - Clinical trials for Human Immunodeficiency Virus

HIV & Drug Abuse Prevention for South African Men

Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the efficacy of randomizing all young men in a neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a control condition, as a means to engage young men in HIV prevention. The investigators hypothesize that the intervention will reduce young men's substance use and increase HIV testing.

NCT ID: NCT02285478 Completed - Clinical trials for Human Immunodeficiency Virus

Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children

DAPHNE
Start date: March 2015
Phase:
Study type: Observational

Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination antiretroviral therapy for treatment of HIV-infected adults according to international guidelines. For children 3-12 years old, FDA has approved once daily dosing of darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved based on a modelling and simulation procedure by the company. This pharmacokinetic study is designed to validate the proposed dosing recommendation for once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.

NCT ID: NCT02282293 Completed - Malaria Clinical Trials

Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)

Start date: December 9, 2014
Phase: Phase 3
Study type: Interventional

This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women between 12 and 28 weeks gestation will be randomized to receive enhanced malaria chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo. Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of age to which the mothers were randomized. All women will receive daily trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be considered a study drug only in infants and children beginning 6 weeks after cessation of breastfeeding and upon exclusion of HIV infection. Women and their children will be followed for 36 months after delivery. In a subset of the study population, the investigators will conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in the study. The investigators will test the hypothesis that for HIV-infected mothers and HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected pregnant women and their children will reduce the incidence of malaria among children from 0 to 24 months of age and improve the development of naturally acquired antimalarial immunity.

NCT ID: NCT02266108 Completed - Clinical trials for Human Immunodeficiency Virus

Economic and Social Empowerment To Increase Upwards Mobility Among Women

ESTIMA
Start date: August 1, 2014
Phase: N/A
Study type: Interventional

The proposed research aims to pilot a multi-strategy structural intervention combining community mobilization to promote gender equity alongside an economic intervention (microfinance and business training) in order to reduce gender-based violence and HIV risk among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA: "Economic and Social Empowerment To Increase Upwards Mobility Among Women." The evaluation will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic intervention) or 2) a wait-list control group. For this preliminary work, at 12 months follow-up, we hypothesize that compared to control participants, intervention participants will have: 1) significantly greater economic security (e.g. decreased debt, increased income, decreased number of sex trades) and 2) significantly greater perceived collective power (i.e. collective efficacy) to address gendered power imbalances within social structures and the community. The long-term goal of this program, upon future refinement and large scale implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately, alleviate a multitude of health burdens among women. Furthermore, we expect that such work will highlight the need for HIV prevention initiatives in Mexico, and elsewhere, to more broadly consider women's 'life contexts' - addressing economic and social burdens in women's lives, to reduce the burden of poverty, gender, and HIV, as well as the intersection of these among women.

NCT ID: NCT02218320 Completed - Clinical trials for Human Immunodeficiency Virus

Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults

Start date: October 2014
Phase:
Study type: Observational

This is a Phase IV, open label, observational study to compare the gastrointestinal tissue concentrations, inflammatory response, and viral replication of two integrase-inhibitors, raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10 subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir. Participants will provide small pieces of tissue, or biopsies, which will be taken from three distinct locations of the large intestine during a colonoscopy procedure. These biopsies will be used to measure the amount of raltegravir or dolutegravir, HIV virus, and inflammatory markers present in the gastrointestinal tract.

NCT ID: NCT02211690 Completed - Clinical trials for Human Immunodeficiency Virus

The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis

dPEP
Start date: August 2014
Phase: Phase 4
Study type: Interventional

This study aims to describe the proportion of participants with non-occupational post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants who should and do cease study drug because: 1. The participant is found to be HIV-infected (study drugs will be ceased until the genotype of the infecting strain is determined) 2. The source is found to be HIV-uninfected The primary study objectives are: 1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF) 2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100) eligible participants will receive dolutegravir (one tablet) with co-formulated emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following exposures: 1. receptive anal intercourse with a source known to be HIV-infected; or 2. receptive anal intercourse with a source of unknown HIV status; or 3. insertive anal intercourse with a source known to be HIV-infected There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e. to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed at the investigator's discretion.

NCT ID: NCT02175680 Completed - HIV Clinical Trials

Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

Start date: April 16, 2014
Phase: Phase 2
Study type: Interventional

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.

NCT ID: NCT02166502 Completed - HIV Clinical Trials

Nevirapine Dosing in Neonates for Prophylaxis of Mother-to-Child-Transmission (MTCT) of HIV Infection

Start date: February 2012
Phase: Phase 3
Study type: Observational

The purpose of this study is to determine whether the current dose of nevirapine recommended in the Ontario Ministry of Health vertical transmission prevention protocol achieves therapeutic drug levels in newborn infants at high risk of HIV infection.