Clinical Trials

MainTitle

The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention (CHAPS)

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2019 by Fatima Mayat

Sponsor
Fatima Mayat

Collaborator
University of Cape Town
University of Liverpool
Imperial College London
MRC/UVRI Uganda Research Unit
Karolinska Institutet
King's College London
London School of Hygiene and Tropical Medicine

Information provided by (Responsible Party)
Fatima Mayat, Wits Health Consortium (Pty) Ltd

ClinicalTrials.gov Identifier
NCT03986970

First received: June 6, 2019
Last updated: December 30, 2019
Last Verified: December 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV/AIDS

Drug : Tenofovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, randomised controlled trial (RCT)
Masking: None (Open Label)
Primary Purpose: Prevention
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)

Further study details as provided by Fatima Mayat, Wits Health Consortium (Pty) Ltd:

Primary Outcome Measures

  • HIV Infection free [ Time Frame: 15 days ]
    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).
Secondary Outcome Measures:
  • Timing [ Time Frame: 1 year ]
    The delay between the timing of last dose of FTC-TDF and FTC-TAF as oral PrEP and the timing of circumcision.
  • Dose [ Time Frame: 1 year ]
    The efficacy of preventing in-vitro HIV infection by dose of FTC-TDF and FTC-TAF as oral PrEP compared to no intervention
  • Blood PrEP Concentrations [ Time Frame: 1 year ]
    Plasma concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.
  • Rectal Fluid PrEP concentrations [ Time Frame: 1 year ]
    Rectal fluid concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.
  • Foreskin tissue PrEP concentration [ Time Frame: 1 year ]
    Foreskin tissue concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
  • Efficacy of post-exposure PrEP [ Time Frame: 1 year ]
    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.

Estimated Enrollment: 144
Study Start Date: November 11, 2019
Estimated Study Completion Date: August 30, 2021
Estimated Primary Completion Date: August 30, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
No Intervention: Arm 1: Control
No PrEP.
Experimental: Arm 2: FTC-TDF
FTC-TDF one day, 5 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 3: FTC-TDF
FTC-TDF one day, 21 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 4: FTC-TDF
FTC-TDF two days, 5 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 5: FTC-TDF
FTC-TDF two days, 21 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 6: FTC-TAF
FTC-TAF one day, 5 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 7: FTC-TAF
FTC-TAF one day, 21 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 8: FTC-TAF
FTC-TAF two days, 5 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Experimental: Arm 9: FTC-TAF
FTC-TAF two days, 21 hours before circumcision.
Drug: Tenofovir

Pre-exposure prophylaxis

Other Name: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide

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

    Eligibility

    Eligibility

    Ages Eligible for Study: 13 Years to 24 Years  
    Sexes Eligible for Study: Male  
    Accepts Healthy Volunteers: Yes  

    Criteria

    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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03986970

Contacts

Contact:   Neil A Martinson +27 11 989 9836 martinson@phru.co.za

Locations

South Africa
The Perinatal HIV Research Unit Recruiting
Johannesburg, Gauteng, South Africa, 1862
Contact: Neil A Martinson    +27 11 989 9836    martinson@phru.co.za
Contact: Fatima Mayat    +27 11 989 9798    mayatf@phru.co.za

Sponsors and Collaborators

Fatima Mayat
University of Cape Town
University of Liverpool
Imperial College London
MRC/UVRI Uganda Research Unit
Karolinska Institutet
King's College London
London School of Hygiene and Tropical Medicine

Investigators

Principal Investigator: Neil A Martinson Perinatal HIV Research Unit
More Information

More Information


Responsible Party: Fatima Mayat, Professor Neil Martinson, Wits Health Consortium (Pty) Ltd  
ClinicalTrials.gov Identifier: NCT03986970   History of Changes  
Other Study ID Numbers: The CHAPS Trial  
Study First Received: June 6, 2019  
Last Updated: December 30, 2019  
Individual Participant Data    
Plan to Share IPD: Undecided  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Keywords provided by Fatima Mayat, Wits Health Consortium (Pty) Ltd:

Pre-exposure prophylaxis

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.