Trial | NCT03986970  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
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.
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
Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP
Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against ex vivo HIV infection using the explant model
To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention trials implementation
Study Started
Nov 11
2019
Primary Completion
Feb 25
2021
Study Completion
Feb 25
2021
Last Update
Aug 02
2022

Drug Tenofovir

Pre-exposure prophylaxis

  • Other names: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide

Arm 1: Control No Intervention

No PrEP.

Arm 2: FTC-TDF Experimental

FTC-TDF one day, 5 hours before circumcision.

Arm 3: FTC-TDF Experimental

FTC-TDF one day, 21 hours before circumcision.

Arm 4: FTC-TDF Experimental

FTC-TDF two days, 5 hours before circumcision.

Arm 5: FTC-TDF Experimental

FTC-TDF two days, 21 hours before circumcision.

Arm 6: FTC-TAF Experimental

FTC-TAF one day, 5 hours before circumcision.

Arm 7: FTC-TAF Experimental

FTC-TAF one day, 21 hours before circumcision.

Arm 8: FTC-TAF Experimental

FTC-TAF two days, 5 hours before circumcision.

Arm 9: FTC-TAF Experimental

FTC-TAF two days, 21 hours before circumcision.

Criteria 

Inclusion Criteria:

Participants must satisfy all the following criteria within 21 days prior to their circumcision visit:

Clinically eligible for either forceps guided, or dorsal slit circumcision
The ability to understand and sign a written informed consent form by participant (and participant's legal guardian if younger than 18 years) prior to participation in any study procedures and to comply with all trial requirements
Male sex at birth
Age 13- 24 years
Haemoglobin >9g/dL
Weight >35Kg
Two negative rapid HIV antibody tests results (manufactured by different companies), dating from 21 days or less prior to VMMC
Two locator information details (including physical address, telephone contacts, email) for contacting of either patient or their parent

Exclusion Criteria:

Any significant acute or chronic medical illness and current therapy that in the opinion of the site investigator would preclude receipt either of investigational products, or VMMC
Any evidence that participant is not suitable for VMMC
No Results Posted