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HIV Infections clinical trials

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NCT ID: NCT03393468 Completed - HIV Infections Clinical Trials

Pharmacokinetic Study of Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults

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

The purpose of this study is to evaluate the pharmacokinetics of dapivirine gel administered rectally to HIV-1 seronegative adults.

NCT ID: NCT03388398 Completed - HIV Infections Clinical Trials

Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe

Start date: January 2012
Phase:
Study type: Observational

This study evaluates the impact of Zimbabwe's program for the prevention of mother-to-child HIV transmission (PMTCT) on vertical transmission of HIV infection and HIV-free survival among infants exposed to HIV. The study will test the hypothesis that the accelerated PMTCT program in Zimbabwe will result in fewer new HIV infections in infants and will increase infant survival.

NCT ID: NCT03387150 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults

Start date: February 28, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.

NCT ID: NCT03386578 Completed - HIV Infections Clinical Trials

Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum

Start date: July 3, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants.

NCT ID: NCT03383211 Completed - HIV Infections Clinical Trials

Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers

IMMUNEO
Start date: June 16, 2017
Phase:
Study type: Observational

Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal circulation through placenta. Even in the absence of a direct (vertical) transmission of pathogens to fetuses, certain infections make the neonates more prone to allergies and some adverse events of early vaccinations. We postulate that the basal immune status of neonates born to HIV and LTBI infected mothers is primed by gestational exposure to immunological active molecules, which could results in an altered response to early BCG vaccination. Transcripts expression identified by RNA sequencing are compared between sets of mother-child and their respective umbilical cord blood, and between groups of infected and non-infected pairs.

NCT ID: NCT03382834 Completed - HIV Infections Clinical Trials

Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors

Start date: April 26, 2018
Phase: Phase 2
Study type: Interventional

This study evaluated the effects of tamoxifen exposure in combination with vorinostat on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy (ART), when compared to vorinostat alone.

NCT ID: NCT03382418 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States

Start date: December 27, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.

NCT ID: NCT03369743 Completed - HIV Infections Clinical Trials

Dual Therapy Etravirine + Raltegravir by Once Daily in HIV-positive Patients (ETRAL QD)

ETRALQD
Start date: January 2, 2018
Phase:
Study type: Observational

Efficacy of etravirin + raltegravir dual therapy was showed in the ANRS 153 ETRAL protocol, in HIV-1 seropositive patients. The use of these two drugs avoids the use of nucleoside reverse transcriptase inhibitors and protease inhibitors, with a real benefit in older patients, who increasingly present contraindications to these drugs' families. The disadvantage of this strategy is twice daily (BID). Pharmacological data suggest that etravirine once a day and raltegravir once a day may provide the same virological efficacy. The objective of our study is to evaluate the ability of ETRAL QD (etravirine 400 mg x1/day + raltegravir 800 mg x1/day) to maintain virologic success at week 48 (W48), after switch, in HIV-patients under ETRAL BID (etravirine 200 mg x2/day + raltegravir 400 mg x2/day). Virological success is defined as absence of virological failure, and virological failure is defined as two consecutive plasma viral loads >50 cp/ml over 2-4 weeks, or one plasma viral load >400 cp/ml. This study will be a multicentric data collection. Data will be collected at W0 (patient characteristics, plasma viral load) and then at W4, W12, W24 and W48 (plasma viral load). If stopping strategy, the reason for stopping will be documented. 125 patients will be included in the six participating centers. Data will be centralized at Pitié-Salpêtrière hospital, Paris, with an anonymized e-CRF.

NCT ID: NCT03369327 Completed - Clinical trials for Human Immunodeficiency Virus

Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

HIV200
Start date: January 1, 2017
Phase: Phase 3
Study type: Interventional

In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

NCT ID: NCT03369249 Completed - HIV Infections Clinical Trials

Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

Start date: December 9, 2017
Phase: N/A
Study type: Interventional

This research study proposes to embed HIV testing outreach workers from a young adult focused medical and HIV treatment program into an alternative sentencing program to deliver a new service delivery model (Link2CARE) that integrates evidence-based protocols for justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU care. Phase 1 has already been completed. In phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session Link2CARE intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with N=15 alternative sentencing program staff.