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HIV Infections clinical trials

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NCT ID: NCT03391921 Active, not recruiting - HIV Infections Clinical Trials

Vaccination Against Human Papillomavirus (HPV) With the 9-valent Vaccine in HIV-positive Women (the Papillon Study)

Papillon
Start date: January 8, 2018
Phase: Phase 4
Study type: Interventional

Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9®Merck) in HIV-positive women aged 15-40 years with fully suppressed HIV viremia on combined antiretroviral therapy. After a first open phase evaluating tolerability of Gardasil9 (from June 2018 to December 2018), an amendment was introduced to randomize women between two different doses schedules: in the first schedule (ARM A), women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule (ARM B) will be 3 doses at 0, 2 and 6 months. Primary outcome is the non-inferiority of the rate of seroconversion against each HPV vaccine genotypes in women seronegative at baseline after either 2 or 3 doses of vaccination (month 7). Secondary outcomes are rate of seroconversion after 3 doses if they have received a third dose, completion of vaccine schedule, vaccine safety, antibody titles, and induction of cellular immunity against HPV contained in the vaccine, incidence of cervical HPV infection and incidence of abnormal cytology after vaccination. The safety of the vaccination (local or systemic reaction and impact on HIV viral control and immunodeficiency level) will be assessed. The cellular immune response will be assessed in a subgroup of patients.

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: NCT03371914 Terminated - HIV/AIDS Clinical Trials

Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria

Start date: August 12, 2017
Phase: N/A
Study type: Interventional

This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. To complete these goals, the study will collect both retrospective and prospective data from CBOs and from centralized information from study partners (Society for Family Health, SFH). In the prospective section of the study, CBOs will be sampled and assigned to either treatment or control groups. Data collected at the CBOs will be aggregated by the CBO managers, and those in the treatment group will receive feedback on their performance on a monthly basis. Those in the treatment group will additionally receive a management training to guide their management practices. Researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to local, national, and international stakeholders.

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.