The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

NCT03986970 | Completed Phase 2

• 1 other identifier: The CHAPS Trial
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS

Keywords

Pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Timing

  1 year

• Dose

  1 year

• Blood PrEP Concentrations

  1 year

• Rectal Fluid PrEP concentrations

  1 year

• Foreskin tissue PrEP concentration

  1 year

Study Arms (9)

Arm 1: Control

NO INTERVENTION

No PrEP.

Arm 2: FTC-TDF

EXPERIMENTAL

FTC-TDF one day, 5 hours before circumcision.

Drug: Tenofovir

Arm 3: FTC-TDF

EXPERIMENTAL

FTC-TDF one day, 21 hours before circumcision.

Drug: Tenofovir

Arm 4: FTC-TDF

EXPERIMENTAL

FTC-TDF two days, 5 hours before circumcision.

Drug: Tenofovir

Arm 5: FTC-TDF

EXPERIMENTAL

FTC-TDF two days, 21 hours before circumcision.

Drug: Tenofovir

Arm 6: FTC-TAF

EXPERIMENTAL

FTC-TAF one day, 5 hours before circumcision.

Drug: Tenofovir

Arm 7: FTC-TAF

EXPERIMENTAL

FTC-TAF one day, 21 hours before circumcision.

Drug: Tenofovir

Arm 8: FTC-TAF

EXPERIMENTAL

FTC-TAF two days, 5 hours before circumcision.

Drug: Tenofovir

Arm 9: FTC-TAF

EXPERIMENTAL

FTC-TAF two days, 21 hours before circumcision.

Drug: Tenofovir

Interventions

Tenofovir DRUG

Pre-exposure prophylaxis

Also known as: Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide

Arm 2: FTC-TDF; Arm 3: FTC-TDF; Arm 4: FTC-TDF; Arm 5: FTC-TDF; Arm 6: FTC-TAF; Arm 7: FTC-TAF; Arm 8: FTC-TAF; Arm 9: FTC-TAF

Eligibility Criteria

• Age: 13 Years - 24 Years
• Gender Eligibility Details: Male genital anatomical features.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wits Health Consortium (Pty) Ltd: lead
• University of Cape Town: collaborator
• University of Liverpool: collaborator
• Imperial College London: collaborator
• MRC/UVRI Uganda Research Unit: collaborator
• Karolinska Institutet: collaborator
• King's College London: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

The Perinatal HIV Research Unit

Johannesburg, Gauteng, 1862, South Africa

Location

Related Publications (1)

• Nash S, Dietrich J, Ssemata AS, Herrera C, O'Hagan K, Else L, Chiodi F, Kelly C, Shattock R, Chirenje M, Lebina L, Khoo S, Bekker LG, Weiss HA, Gray C, Stranix-Chibanda L, Kaleebu P, Seeley J, Martinson N, Fox J; CHAPS team. Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa-study protocol for a mixed-methods study including a randomised controlled trial. Trials. 2020 Oct 30;21(1):900. doi: 10.1186/s13063-020-04760-x.

  PMID: 33121503 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Tenofovir; Emtricitabine; tenofovir alafenamide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Neil A Martinson

  Perinatal HIV Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomised controlled trial (RCT)

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: November 11, 2019
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: August 2, 2022

Record last verified: 2021-04

Locations

ZA (1)