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NCT ID: NCT02245022 Completed - HIV Clinical Trials

Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

DolPHIN1
Start date: March 14, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women Rationale: In developing countries many women present with a new HIV diagnosis in late pregnancy, and are at high risk of transmitting infection during delivery. Moreover, women may acquire NNRTI resistance from primary transmission, or use of nevirapine (NVP) in previous pregnancies. In these circumstances, DTG is likely to be more effective in reducing mother to child transmission of HIV than NNRTI-based regimens. Study design: HIV positive pregnant women presenting with untreated HIV infection in late (≥28 -36 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) or standard of care (nevirapine or efavirenz) + 2 NRTIs. PK (0-24h) profile will be sampled in third trimester and post-partum. Although this is primarily a PK study (and has been powered as such) randomisation is included to allow comparison of plasma HIV VL responses against standard of care (NVP or EFV) and is essential for evaluation of secondary endpoints of safety and efficacy of DTG in pregnancy. Number recruited N=30 per group

NCT ID: NCT02242799 Completed - HIV Clinical Trials

Dolutegravir Interactions With Artemisinin-based Combination Therapies

DolACT
Start date: June 2015
Phase: Phase 1
Study type: Interventional

Malaria and HIV are found in the same regions of the world and developing countries are most affected by both diseases. For malaria, new drugs have been introduced called ACTs. These drugs are effective against malaria but little is known about how the levels of these drugs in blood relate to how effective these drugs are. For HIV, a new drug has been developed called dolutegravir which has potential to be widely used in developing countries. This proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs and vice versa. In total, 46 healthy volunteers will participate in this study.

NCT ID: NCT02238327 Completed - HIV Clinical Trials

Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes

LEAP
Start date: September 2014
Phase:
Study type: Observational

The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk factors and that persistent viral infection including residual HIV is linked to HIV COPD.

NCT ID: NCT02237326 Completed - HIV Clinical Trials

Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women

SAVE
Start date: October 2011
Phase: N/A
Study type: Interventional

The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women. The investigators randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were based on the colposcopy exam done at the study visit. The investigators then compared outcomes between the two groups to assess the test characteristics of both VIA and VILI.

NCT ID: NCT02235662 Completed - HIV Clinical Trials

Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone

Start date: October 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR), TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate acceptability of the IVRs.

NCT ID: NCT02228044 Completed - HIV Clinical Trials

Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment

Start date: September 2008
Phase: N/A
Study type: Interventional

This study examines whether an integrated alcohol/substance abuse, suicide, and HIV prevention protocol is associated with lower onset and frequency of alcohol and other drug use, suicidal behavior, and high risk sexual behavior among adolescents receiving community based mental health care.

NCT ID: NCT02227277 Active, not recruiting - HIV Clinical Trials

Reducing Proviral HIV DNA With Interferon-a

BEAT-HIV
Start date: February 11, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if treatment with pegylated interferon alpha 2b (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART). A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV eradication. By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment should be considered as a component of future viral eradication strategies.

NCT ID: NCT02223390 Completed - HIV Clinical Trials

Improving the Health of South African Women With Traumatic Stress in HIV Care

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

In this study, the investigators propose to develop Improving AIDS Care after Trauma (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment for traumatic stress. The intervention will target women in South Africa who have histories of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.

NCT ID: NCT02223130 Completed - HIV Clinical Trials

Addressing Discrimination and Mistrust Among Black Men: Phase III

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this research study is to test a group program aimed at improving the quality of life of HIV+ Black men who have sex with men. The group will address ways to cope with discrimination and will help men examine mistrust that they may have about healthcare, including doctors and other healthcare providers and HIV medications. The aim is to provide a supportive community for HIV+ Black men.

NCT ID: NCT02219217 Completed - HIV Clinical Trials

SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers

Start date: October 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to look at the levels of three HIV medications: dolutegravir, elvitegravir and cobicistat in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 10 days dolutegravir on a first stage and a combination of elitegravir and cobicistat in a second stage. If the participant decides to take part, the duration of the study will be up to 38 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit which takes place 7 to 14 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications the participant is taking at all times during the study.