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HIV clinical trials

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NCT ID: NCT03836833 Not yet recruiting - HIV Clinical Trials

Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation

Start date: April 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children. The study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.

NCT ID: NCT03831945 Recruiting - HIV Clinical Trials

Combination Therapy With VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions

Start date: March 22, 2019
Phase: Phase 1
Study type: Interventional

Background: A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up. People can also develop resistance or permanent side effects. Researchers want to see if 2 new drugs can help control HIV when a person is not on ART. Objective: To see if VRC01 and 10-1074 are safe and control HIV when a person is not on ART. Eligibility: Adults 18 65 with HIV Design: All participants must agree to practice safer sex. Those who can get pregnant will have a pregnancy test every visit. Participants will be screened with: Physical exam Medicine review Blood and urine tests Some participants may need to change their HIV medicine for a brief period of time during the study. A few weeks later, participants will repeat screening tests and stop taking their HIV medicines. Interruption phase 1: Participants will have blood tests every 2 weeks, and repeat screening tests every 4 weeks. Treatment phase: Once their HIV reaches a certain level in the blood, participants will get the 2 study drugs or a salt water placebo. They will not know which they get. Each substance will be given through a thin tube in an arm vein for about 1 hour. Participants will restart their HIV medicines and repeat screening tests every 4 weeks. Interruption phase 2: Once the level of HIV in the blood becomes undetectable for 3 months, participants will again stop taking their HIV medicines and have blood tests every 2 weeks to monitor the level of HIV in the blood. Participants will restart their medicines by week 24. They will start sooner if they have certain symptoms or blood levels of HIV become too high. They will repeat most screening tests 3 times over 24 weeks.

NCT ID: NCT03826199 Not yet recruiting - Hiv Clinical Trials

Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

Start date: April 1, 2019
Phase: Phase 4
Study type: Interventional

The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.

NCT ID: NCT03823911 Recruiting - Clinical trials for Cardiovascular Diseases

Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

Start date: November 18, 2018
Phase: Phase 4
Study type: Interventional

This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.

NCT ID: NCT03810170 Completed - Hiv Clinical Trials

Prevention of HIV/AIDS and STDs in Women Over Fifty

Start date: September 1, 2009
Phase: Phase 2
Study type: Interventional

In response to the increasing rates of HIV/STD infections among women over the age of 50, especially minority women, and in the attempt to reduce HIV/STD risks for over ten million older adult American women who are impacted by gray divorce and at risk for unsafe sex, the investigators will create, test, and commercialize a novel positive psychology-based "SmartWeb" intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among culturally-diverse older divorced or separated women who are dating. This large end-user market for the proposed HIV/STD risk reduction intervention will greatly facilitate commercialization through advertisements, marketing research based on data mining, and in collaboration with manufacturers of condoms, and other large companies offering health products and services to older women.

NCT ID: NCT03805451 Not yet recruiting - HIV Clinical Trials

Life Steps for PrEP for Youth

Start date: February 21, 2019
Phase: N/A
Study type: Interventional

This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM). Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to PrEP.

NCT ID: NCT03774160 Active, not recruiting - HIV Clinical Trials

Community and Systems-level HIV Prevention in Peru

Start date: April 6, 2017
Phase: N/A
Study type: Interventional

This project involves adapting 3 new intervention components, and then testing them, in combination with a multi-level, community-based intervention, to promote HIV prevention and sexual health among men who have sex with men and transgender women in Lima, Peru. The total intervention has a community-based intervention and a systems-level intervention at the hospital where people living with HIV get care and medications.

NCT ID: NCT03768986 Recruiting - HIV Clinical Trials

Incentives for HIV Testing in Women

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

African American and Latina women, as well as women living in poverty, are at disproportionate risk for contracting HIV (CDC, 2018). Prevalence is increased further in these women if they have other risk factors for HIV, including substance use, history of intimate partner violence, and homelessness. Despite the relatively high prevalence rates in these populations, many women with these characteristics have never been tested for HIV (CDC, 2016a). Knowledge of one's HIV status is crucial for rapid access to treatment and reducing the spread of HIV. Thus, effective interventions for enhancing testing in these women are an imminent need. This project will evaluate a systems approach for enhancing HIV testing in high risk women. The investigators will train ~50 staff from multiple community agencies that provide services to high risk women to encourage HIV testing and deliver reinforcement for testing. After staff training, 334 women recruited at these community agencies will be randomized to standard care referral procedures plus HIV risk reduction education or the same plus reinforcement, in which they can receive monetary compensation for completing HIV testing at study initiation and for repeat testing 6 and 12 months later. This project evaluates new models to promote HIV testing. It institutes trainings and provides direct resources for integrating reinforcement-based HIV testing referral procedures to women accessing services at substance abuse treatment clinics, Federally Qualified Heath Centers, domestic violence agencies, and homeless shelters. Trainings address systemic and structural issues and provide concrete methods and resources to enhance testing (i.e., reinforcers).

NCT ID: NCT03762772 Recruiting - Hiv Clinical Trials

Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG

Start date: December 10, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG). This study will be the first-in-human study for a vaginally administered TAF/EVG insert and will evaluate safety, PK and PD after a single dose. It is hypothesized that the combination insert will be safe and well-tolerated by study participants and that the insert will offer an expanded window of preventive activity and a regimen with flexibility and forgiveness.

NCT ID: NCT03762382 Enrolling by invitation - HIV Clinical Trials

Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring

Start date: December 12, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.