The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

HIV/AIDS Clinical Trial

— CHAPS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986970
• Other study ID #: The CHAPS Trial
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

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

External Links

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