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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03986970
Other study ID # The CHAPS Trial
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 11, 2019
Est. completion date February 25, 2021

Study information

Verified date April 2021
Source Wits Health Consortium (Pty) Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 13 Years to 24 Years
Eligibility Inclusion Criteria: Participants must satisfy all the following criteria within 21 days prior to their circumcision visit: 1. Clinically eligible for either forceps guided, or dorsal slit circumcision 2. 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 3. Male sex at birth 4. Age 13- 24 years 5. Haemoglobin >9g/dL 6. Weight >35Kg 7. Two negative rapid HIV antibody tests results (manufactured by different companies), dating from 21 days or less prior to VMMC 8. Two locator information details (including physical address, telephone contacts, email) for contacting of either patient or their parent Exclusion Criteria: 1. 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 2. Any evidence that participant is not suitable for VMMC

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir
Pre-exposure prophylaxis

Locations

Country Name City State
South Africa The Perinatal HIV Research Unit Johannesburg Gauteng

Sponsors (8)

Lead Sponsor Collaborator
Wits Health Consortium (Pty) Ltd Imperial College London, Karolinska Institutet, King's College London, London School of Hygiene and Tropical Medicine, MRC/UVRI Uganda Research Unit, University of Cape Town, University of Liverpool

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary HIV Infection free We will ascertain the proportion of patients' foreskin tissue that is not infected with HIV 15 days following our ex-vivo HIV challenge. We will use the concentration of p24 antigen (pg/mL) at day15 and also report the slope of the p24 curves from day 3 to 15 (pg/mL per day) and also the AUC day 3 to 15 (pg/mL days). 15 days
Secondary Timing The delay between the timing of last dose of FTC-TDF and FTC-TAF as oral PrEP and the timing of circumcision. 1 year
Secondary Dose The efficacy of preventing in-vitro HIV infection by dose of FTC-TDF and FTC-TAF as oral PrEP compared to no intervention 1 year
Secondary Blood PrEP Concentrations Plasma concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection. 1 year
Secondary Rectal Fluid PrEP concentrations Rectal fluid concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection. 1 year
Secondary Foreskin tissue PrEP concentration Foreskin tissue concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection 1 year
Secondary Efficacy of post-exposure PrEP The proportion of participants' foreskin tissue that remains HIV infection free in the ex-vivo challenge model when additional doses of PrEP are added to that model. 1 year
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