NCT03986970

The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Wits Health Consortium (Pty) Ltd · Academic / Other
• Sex: Male
• Age: 13 Years – 24 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
DRUG	Tenofovir	Pre-exposure prophylaxis

Timeline

• Start date: 2019-11-11
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2019-06-14
• Last updated: 2022-08-02

Locations

1 site across 1 country: South Africa