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HIV/AIDSPhase 2CHAPSNCT03986970

The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

A Phase 2 study testing Tenofovir in people with HIV/AIDS, run by Wits Health Consortium (Pty) Ltd at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 24 years, men onlyHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
Tenofovir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSouth Africa
Study dates
11 Nov 2019to 25 Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • The Perinatal HIV Research Unit

    Johannesburg, Gauteng, 1862

Other trials in South Africa

About this study

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)

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.

Read the 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
Conditions
HIV/AIDS
Being tested
Tenofovir
Keywords
Pre-exposure prophylaxis
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TenofovirDrug

    Also called Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide

    Pre-exposure prophylaxis

Study groups in NCT03986970
Study groupRoleWhat they receive
Arm 1: ControlNo interventionNo PrEP.
Arm 2: FTC-TDFExperimentalFTC-TDF one day, 5 hours before circumcision.
Receives: Drug: Tenofovir
Arm 3: FTC-TDFExperimentalFTC-TDF one day, 21 hours before circumcision.
Receives: Drug: Tenofovir
Arm 4: FTC-TDFExperimentalFTC-TDF two days, 5 hours before circumcision.
Receives: Drug: Tenofovir
Arm 5: FTC-TDFExperimentalFTC-TDF two days, 21 hours before circumcision.
Receives: Drug: Tenofovir
Arm 6: FTC-TAFExperimentalFTC-TAF one day, 5 hours before circumcision.
Receives: Drug: Tenofovir
Arm 7: FTC-TAFExperimentalFTC-TAF one day, 21 hours before circumcision.
Receives: Drug: Tenofovir
Arm 8: FTC-TAFExperimentalFTC-TAF two days, 5 hours before circumcision.
Receives: Drug: Tenofovir
Arm 9: FTC-TAFExperimentalFTC-TAF two days, 21 hours before circumcision.
Receives: Drug: Tenofovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 15 days

Secondary outcomes (6)

  1. Timing

    The delay between the timing of last dose of FTC-TDF and FTC-TAF as oral PrEP and the timing of circumcision.

    Measured: 1 year

  2. Dose

    The efficacy of preventing in-vitro HIV infection by dose of FTC-TDF and FTC-TAF as oral PrEP compared to no intervention

    Measured: 1 year

  3. Blood PrEP Concentrations

    Plasma concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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

    Measured: 1 year

  6. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start11 Nov 2019
  3. Primary completion25 Feb 2021
  4. Study completion25 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, randomised controlled trial (RCT)
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986970
Sponsor's protocol ID
The CHAPS Trial
Acronym
CHAPS
Status last verified
Apr 2021
First submitted
6 Jun 2019
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be shared with callaborators.

Publications

  • Webb EL, Petkov S, Yun H, Else L, Lebina L, Serwanga J, Pillay AAP, Seiphetlo TB, Mugaba S, Namubiru P, Odoch G, Opoka D, Ssemata AS, Kaleebu P, Khoo S, Martinson N, Fox J, Gray CM, Herrera C, Chiodi F. Gene expression of tight junctions in foreskin is not affected by HIV pre-exposure prophylaxis. Front Immunol. 2024 Nov 6;15:1415475. doi: 10.3389/fimmu.2024.1415475. eCollection 2024.

    PubMed 39569196

  • 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.

    PubMed 33121503

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tenofovir in people with HIV/AIDS, run by Wits Health Consortium (Pty) Ltd at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV Infection free (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986970, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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