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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03986970
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : August 2, 2022
Sponsor:
Collaborators:
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):
Wits Health Consortium (Pty) Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Drug: Tenofovir Phase 2

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
  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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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)
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : February 25, 2021
Actual Study Completion Date : February 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male genital anatomical features.
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986970


Locations
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South Africa
The Perinatal HIV Research Unit
Johannesburg, Gauteng, South Africa, 1862
Sponsors and Collaborators
Wits Health Consortium (Pty) Ltd
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
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Principal Investigator: Neil A Martinson Perinatal HIV Research Unit
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wits Health Consortium (Pty) Ltd
ClinicalTrials.gov Identifier: NCT03986970    
Other Study ID Numbers: The CHAPS Trial
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared with callaborators.

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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 Wits Health Consortium (Pty) Ltd:
Pre-exposure prophylaxis
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
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
 Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents