Clinical Trials Logo

Clinical Trial Summary

To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.


Clinical Trial Description

1. Investigate the timing and dose of FTC-TDF and FTC-TAF as oral PrEP and in vitro PEP (applied directly to removed foreskin tissue) required to prevent ex vivo HIV infection in foreskin tissue and blood using the explant model 2. Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection 3. Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP 4. Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against ex vivo HIV infection using the explant model 5. To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention trials implementation ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03986970
Study type Interventional
Source Wits Health Consortium (Pty) Ltd
Contact
Status Completed
Phase Phase 2
Start date November 11, 2019
Completion date February 25, 2021

See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03289676 - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV Phase 1
Completed NCT03215901 - Life Plans Intervention Study N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting NCT04064567 - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK N/A
Completed NCT04013295 - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya N/A
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT03984136 - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM N/A
Completed NCT02928900 - Patient Actor Training to Improve HIV Services for Adolescents in Kenya N/A
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02376582 - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS Phase 1
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Completed NCT01616940 - Minority AIDS Initiative Retention and Re-Engagement Project N/A
Terminated NCT01443923 - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV Phase 4
Completed NCT01910714 - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth N/A
Completed NCT01084421 - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos N/A
Completed NCT01596322 - International HIV Antiretroviral Adherence, Resistance and Survival N/A
Completed NCT03643705 - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention N/A
Completed NCT03923231 - Pharmacokinetics of Atazanavir in Special Populations