HIV-1-infectionPhase 2NCT03074786
Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)
A Phase 2 study testing Dapivirine and Truvada in people with HIV-1-infection, run by International Partnership for Microbicides, Inc. at 1 site in South Africa.
Trial summary
Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. Read more about this study
- Who is it for?
- Ages 16 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dapivirine and Truvada
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2017to 30 Dec 2020
- 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 16 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
- Able and willing to provide adequate locator information and comply with all study procedural requirements.
Who cannot join
- Become Pregnant and/or use oral PrEP outside the context of study.
- At Screening or Enrollment, has a positive HIV test.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
CAPRISA, eThekwini Clinical Research Site
Durban, KwaZulu-Natal
About this study
Official title: A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.
Read the detailed description
The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.
- Conditions
- HIV-1-infection
- Being tested
- Dapivirine, Truvada
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapivirineDrug
Also called Vaginal Ring
Silicone elastomer vaginal matrix ring
TruvadaDrug
Also called Emtricitabine/tenofovir
Tablets to be taken orally daily
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Matrix Ring | Experimental | Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month. Receives: Drug: Dapivirine |
| Oral Emtricitanbine/Tenofovir Disoproxil | Experimental | Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by grade 2 or higher adverse event.
To compare the safety profiles of FTC/TDF oral tablet administered daily and dapivirine vaginal matrix ring (25 mg) inserted for use of each study product in an adolescent and young adult female population
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startNov 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: Study was transferred to partner who will conduct under its own IND
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Dianne M Rausch, PHD, Study director, US National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074786
- Sponsor's protocol ID
- MTN-034/IPM 045
- Status last verified
- Sep 2017
- First submitted
- 10 Feb 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ngure K, Browne EN, Reddy K, Friedland BA, van der Straten A, Palanee-Phillips T, Nakalega R, Gati B, Kalule HN, Siziba B, Soto-Torres L, Nair G, Garcia M, Celum C, Roberts ST. Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial. AIDS Behav. 2024 Sep;28(9):2990-3000. doi: 10.1007/s10461-024-04382-3. Epub 2024 Jun 9.
PubMed 38852114
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
- ClinicalTrials.gov ID
- NCT03074786
- Acronym / sponsor ID
- MTN-034/IPM 045
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was transferred to partner who will conduct under its own IND
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- Nov 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.
Detailed description
The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Vaginal Matrix Ring | Experimental | Drug: DapivirineDapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month. |
| Oral Emtricitanbine/Tenofovir Disoproxil | Experimental | Drug: TruvadaEmtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
- Able and willing to provide adequate locator information and comply with all study procedural requirements.
Key exclusion criteria (2 listed)
- Become Pregnant and/or use oral PrEP outside the context of study.
- At Screening or Enrollment, has a positive HIV test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapivirineAlso: Vaginal RingSilicone elastomer vaginal matrix ring | Drug | Vaginal Matrix Ring |
| TruvadaAlso: Emtricitabine/tenofovirTablets to be taken orally daily | Drug | Oral Emtricitanbine/Tenofovir Disoproxil |
Primary outcome
Safety assessed by grade 2 or higher adverse event.
Time frame: 12 months
To compare the safety profiles of FTC/TDF oral tablet administered daily and dapivirine vaginal matrix ring (25 mg) inserted for use of each study product in an adolescent and young adult female population
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Derived from this study: PubMed 38852114Ngure K, Browne EN, Reddy K, Friedland BA, van der Straten A, Palanee-Phillips T, Nakalega R, Gati B, Kalule HN, Siziba B, Soto-Torres L, Nair G, Garcia M, Celum C, Roberts ST. Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial. AIDS Behav. 2024 Sep;28(9):2990-3000. doi: 10.1007/s10461-024-04382-3. Epub 2024 Jun 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianne M Rausch, PHD study director
US National Institutes of Health (NIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapivirine and Truvada in people with HIV-1-infection, run by International Partnership for Microbicides, Inc. 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 2 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: withdrawn, as of the sponsor's last update on 8 Sep 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety assessed by grade 2 or higher adverse event. (time frame: 12 months). 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 NCT03074786, which also lists 1 linked publication.
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 8 Sep 2017.