HIV InfectionsPhase 3ASPIRENCT01617096
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
A Phase 3 study testing Dapivirine Vaginal Ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 7 sites in 4 countries.
Trial summary
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dapivirine Vaginal Ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,629 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 24 Jul 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 through 45 years (inclusive) at screening, verified per site SOPs; within this range, sites may restrict the upper age limit per site SOPs, to target women at high risk of HIV infection
- Able and willing to provide written informed consent to be screened for and to take part in the study
- Able and willing to provide adequate locator information, as defined in site SOPs
- HIV-uninfected based on testing performed by study staff at screening and enrollment (per applicable algorithm in Appendix II)
- Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
- Using an effective method of contraception at enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine device (IUD); and sterilization (of participant, as defined in site SOPs)
- At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation -- Note: Tampons may be used for the duration of the trial.
Who cannot join
- Per participant report at screening:
- Intends to become pregnant during study participation
- Plans to relocate away from the study site during study participation
- Plans to travel away from the study site for more than 8 consecutive weeks during study participation
- Is pregnant
- -- Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
Show all 34Show fewer
- Currently breastfeeding
- Diagnosed with urinary tract infection (UTI)
- -- Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 28 days of obtaining informed consent for screening, the participant may be enrolled.
- Diagnosed with pelvic inflammatory disease, an STI or reproductive tract infection (RTI) requiring treatment per current WHO guidelines
- -- Note: Otherwise eligible participants diagnosed during screening with pelvic inflammatory disease or STI/RTI requiring treatment per WHO guidelines - other than asymptomatic BV and asymptomatic candidiasis - are offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 28 days of obtaining informed consent for screening, the participant may be enrolled. Genital warts requiring treatment also must be treated prior to enrollment. Genital warts requiring therapy are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.
- Has a clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
- Note: Cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the Investigator of Record (IoR)/designee is considered expected non-menstrual bleeding and is not exclusionary.
- Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 28 days of providing informed consent for screening, the participant may be enrolled.
- Participant report and/or clinical evidence of any of the following:
- Known adverse reaction to any of the study products (ever)
- Known adverse reaction to latex (ever)
- Chronic vaginal candidiasis
- Non-therapeutic injection drug use in the 12 months prior to Screening
- Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to enrollment
- Last pregnancy outcome 90 days or less prior to enrollment
- Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) 90 days or less prior to enrollment
- Recent participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment
- Participation in the MTN-003, Vaginal and Oral Interventions to Control the Epidemic (VOICE) clinical trial, or any other HIV prevention study using systemic or topical antiretroviral medications, within 12 months of enrollment
- As determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease, including active tuberculosis
- Has any of the following laboratory abnormalities at Screening Visit:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
- Creatinine Grade 2 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
- Hemoglobin Grade 2 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
- Platelet count Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
- Pap result Grade 2 or higher according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)
- Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process.
- Note: Women with a documented normal result within the 12 months prior to enrollment need not have Pap smear during the screening period. Women with a Grade 1 abnormal Pap smear can be enrolled upon completion of the initial phase of evaluation if no current treatment is indicated (based on local standard of care for management of abnormal cervical cytology). Need for a repeat Pap within 6 months does not preclude enrollment prior to that result becoming available.
- Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
South Africa3 sites
Desomond Tutu HIV Center
Cape Town
CAPRISA, eThekwini Clinical Research Site
Durban, KwaZulu-Natal
Wits Reproductive Health and HIV Institute
Johannesburg
Malawi2 sites
College of Medicine - Johns Hopkins University Research Project
Blantyre
UNC Project
Lilongwe
Zimbabwe1 site
UZ-Obstetrics & Gynecology Research Clinic at Spillhaus
Belgravia, Harare
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
Read the detailed description
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women." MTN-020 will enroll approximately 3676 sexually active HIVnegative women aged 18-45 years randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a placebo vaginal ring. Rings will be inserted once every 28 days for 12 consecutive months. MTN expects to initiate this study in August 2012.
- Conditions
- HIV Infections
- Being tested
- Dapivirine Vaginal Ring, Placebo Ring
- Keywords
- HIV Infections, Anti-HIV agents, HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine Vaginal RingCombination product
Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months
Placebo RingCombination product
Vaginal ring containing no drug substance
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine Vaginal Ring | Experimental | Vaginal ring containing 25mg dapivirine Receives: Combination Product: Dapivirine Vaginal Ring |
| Placebo Ring | Placebo comparator | Vaginal ring containing no drug substance Receives: Combination Product: Placebo Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.
The primary endpoint is HIV-1 seroconversion as measured by rapid and specialised laboratory testing according to comprehensive HIV testing algorithm. Endpoint confirmation of HIV infection is by Western Blot.
Measured: minimum of 12 months and a maximum of 14 months per participant
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks).
Participants with grade 2 adverse events, judged to be related to investigational product, grade 3 and grade 4 adverse events and all serious adverse events.
DAIDS severity grades are defined as follows:
Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
Measured: minimum of 12 months and a maximum of 14 months per participant
Secondary outcomes (3)
Adherence to the Dapivirine Vaginal Ring.
Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use.
Adherence was defined as a dapivirine ring residual level <=23.5 mg and dapivirine plasma level >= 95 pg/mL.
Measured: 12 months per participant
Acceptability of the DVR and Placebo Vaginal Ring
Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Percentage of participants with positive response. Response of 'likely' or 'very likely' to the question: 'If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this trial, how likely would you be to keep it inserted in your vagina every day?'
Measured: 12 months per participant
Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.
The analysis of HIV-1 drug resistance will be primarily descriptive in nature, and will depend on the pattern of resistance mutations observed in the HIV-1 seroconverters. The percentage of HIV-1 seroconverters with at least one HIV-1 drug resistant mutation will be presented overall, and by treatment arm, with corresponding 95% CIs.
Measured: minimum of 12 months and a maximum of 14 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study start24 Jul 2012
- Primary completion3 Jul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,629 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jared Baeten, MD, PhD, Study chair, International Clinical Research Center, Department of Global Health, University of WashingtonThesla Palanee, PhD, Study chair, Wits Reproductive Health and HIV Institute (WRHI), Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617096
- Sponsor's protocol ID
- MTN-020
- Other IDs
- UM1AI068633-06
- Acronym
- ASPIRE
- Status last verified
- Dec 2022
- First submitted
- 8 Jun 2012
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stalter RM, Dong TQ, Hendrix CW, Palanee-Phillips T, van der Straten A, Hillier SL, Kiweewa FM, Mgodi NM, Marzinke MA, Bekker LG, Soto-Torres L, Baeten JM, Brown ER; MTN-020/ASPIRE Study Team. Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring. J Infect Dis. 2024 Apr 12;229(4):1158-1165. doi: 10.1093/infdis/jiad550.
PubMed 38099506Browne EN, Brown ER, Palanee-Phillips T, Reddy K, Naidoo L, Jeenarain N, Nair G, Husnik MJ, Singh D, Scheckter R, Soto-Torres L, Baeten JM, van der Straten A; MTN-020/ASPIRE Study Team. Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2022 Aug 1;90(4):418-424. doi: 10.1097/QAI.0000000000002990.
PubMed 35344520Leslie J, Kiweewa F, Palanee-Phillips T, Bunge K, Mhlanga F, Kamira B, Baeten J, Katz A, Hillier S, Montgomery E; MTN-020/ASPIRE Study Team. Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa. BMC Womens Health. 2021 Apr 23;21(1):175. doi: 10.1186/s12905-021-01321-5.
PubMed 33892693Mayo AJ, Browne EN, Montgomery ET, Torjesen K, Palanee-Phillips T, Jeenarain N, Seyama L, Woeber K, Harkoo I, Reddy K, Tembo T, Mutero P, Tauya T, Chitukuta M, Gati Mirembe B, Soto-Torres L, Brown ER, Baeten JM, van der Straten A; MTN-020/ASPIRE study team. Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial. AIDS Behav. 2021 Aug;25(8):2430-2440. doi: 10.1007/s10461-021-03205-z. Epub 2021 Mar 13.
PubMed 33713213Palanee-Phillips T, Brown ER, Szydlo D, Matovu Kiweewa F, Pather A, Harkoo I, Nair G, Soto-Torres L, Hillier SL, Baeten JM; MTN-020/ASPIRE Study Team. Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study. AIDS. 2019 Aug 1;33(10):1619-1622. doi: 10.1097/QAD.0000000000002260.
PubMed 31306167Kiweewa FM, Brown E, Mishra A, Nair G, Palanee-Phillips T, Mgodi N, Nakabiito C, Chakhtoura N, Hillier SL, Baeten JM; MTN-020/ASPIRE Study Team. Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women. J Int AIDS Soc. 2019 Feb;22(2):e25257. doi: 10.1002/jia2.25257.
PubMed 30816632Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis. 2019 Jul 18;69(3):523-529. doi: 10.1093/cid/ciy909.
PubMed 30346511Mensch BS, Richardson BA, Husnik M, Brown ER, Kiweewa FM, Mayo AJ, Baeten JM, Palanee-Phillips T, van der Straten A; MTN-020/ASPIRE study team. Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE. AIDS Behav. 2019 Feb;23(2):504-512. doi: 10.1007/s10461-018-2261-8.
PubMed 30218318Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM, Matovu Kiweewa F, Nair G, Mhlanga F, Siva S, Bekker LG, Jeenarain N, Gaffoor Z, Martinson F, Makanani B, Pather A, Naidoo L, Husnik M, Richardson BA, Parikh UM, Mellors JW, Marzinke MA, Hendrix CW, van der Straten A, Ramjee G, Chirenje ZM, Nakabiito C, Taha TE, Jones J, Mayo A, Scheckter R, Berthiaume J, Livant E, Jacobson C, Ndase P, White R, Patterson K, Germuga D, Galaska B, Bunge K, Singh D, Szydlo DW, Montgomery ET, Mensch BS, Torjesen K, Grossman CI, Chakhtoura N, Nel A, Rosenberg Z, McGowan I, Hillier S; MTN-020-ASPIRE Study Team. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2121-2132. doi: 10.1056/NEJMoa1506110. Epub 2016 Feb 22.
PubMed 26900902
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
- ClinicalTrials.gov ID
- NCT01617096
- Acronym / sponsor ID
- ASPIRE / MTN-020
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Anti-HIV agents, HIV-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,629 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Jul 2012 (actual)
- Primary completion
- 3 Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 16 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
Detailed description
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women." MTN-020 will enroll approximately 3676 sexually active HIVnegative women aged 18-45 years randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a placebo vaginal ring. Rings will be inserted once every 28 days for 12 consecutive months. MTN expects to initiate this study in August 2012.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine Vaginal Ring | Experimental | Combination Product: Dapivirine Vaginal RingVaginal ring containing 25mg dapivirine |
| Placebo Ring | Placebo comparator | Combination Product: Placebo RingVaginal ring containing no drug substance |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 through 45 years (inclusive) at screening, verified per site SOPs; within this range, sites may restrict the upper age limit per site SOPs, to target women at high risk of HIV infection
- Able and willing to provide written informed consent to be screened for and to take part in the study
- Able and willing to provide adequate locator information, as defined in site SOPs
- HIV-uninfected based on testing performed by study staff at screening and enrollment (per applicable algorithm in Appendix II)
- Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
Key exclusion criteria (34 listed)
- Per participant report at screening:
- Is pregnant
- -- Note: A documented negative pregnancy test performed by study staff is required for inclusion; however a self-reported pregnancy is adequate for exclusion from the study.
- Currently breastfeeding
- Diagnosed with urinary tract infection (UTI)
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 |
|---|---|---|
| Dapivirine Vaginal RingDosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months | Combination product | Dapivirine Vaginal Ring |
| Placebo RingVaginal ring containing no drug substance | Combination product | Placebo Ring |
Primary outcome
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.
Time frame: minimum of 12 months and a maximum of 14 months per participant
The primary endpoint is HIV-1 seroconversion as measured by rapid and specialised laboratory testing according to comprehensive HIV testing algorithm. Endpoint confirmation of HIV infection is by Western Blot.
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks).
Time frame: minimum of 12 months and a maximum of 14 months per participant
Participants with grade 2 adverse events, judged to be related to investigational product, grade 3 and grade 4 adverse events and all serious adverse events. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
3 secondary outcomes
Adherence to the Dapivirine Vaginal Ring.
Time frame: 12 months per participant
Acceptability of the DVR and Placebo Vaginal Ring
Time frame: 12 months per participant
Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.
Time frame: minimum of 12 months and a maximum of 14 months per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38099506Stalter RM, Dong TQ, Hendrix CW, Palanee-Phillips T, van der Straten A, Hillier SL, Kiweewa FM, Mgodi NM, Marzinke MA, Bekker LG, Soto-Torres L, Baeten JM, Brown ER; MTN-020/ASPIRE Study Team. Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring. J Infect Dis. 2024 Apr 12;229(4):1158-1165. doi: 10.1093/infdis/jiad550.
- Derived from this study: PubMed 35344520Browne EN, Brown ER, Palanee-Phillips T, Reddy K, Naidoo L, Jeenarain N, Nair G, Husnik MJ, Singh D, Scheckter R, Soto-Torres L, Baeten JM, van der Straten A; MTN-020/ASPIRE Study Team. Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2022 Aug 1;90(4):418-424. doi: 10.1097/QAI.0000000000002990.
- Derived from this study: PubMed 33892693Leslie J, Kiweewa F, Palanee-Phillips T, Bunge K, Mhlanga F, Kamira B, Baeten J, Katz A, Hillier S, Montgomery E; MTN-020/ASPIRE Study Team. Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa. BMC Womens Health. 2021 Apr 23;21(1):175. doi: 10.1186/s12905-021-01321-5.
- Derived from this study: PubMed 33713213Mayo AJ, Browne EN, Montgomery ET, Torjesen K, Palanee-Phillips T, Jeenarain N, Seyama L, Woeber K, Harkoo I, Reddy K, Tembo T, Mutero P, Tauya T, Chitukuta M, Gati Mirembe B, Soto-Torres L, Brown ER, Baeten JM, van der Straten A; MTN-020/ASPIRE study team. Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial. AIDS Behav. 2021 Aug;25(8):2430-2440. doi: 10.1007/s10461-021-03205-z. Epub 2021 Mar 13.
- Derived from this study: PubMed 31306167Palanee-Phillips T, Brown ER, Szydlo D, Matovu Kiweewa F, Pather A, Harkoo I, Nair G, Soto-Torres L, Hillier SL, Baeten JM; MTN-020/ASPIRE Study Team. Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study. AIDS. 2019 Aug 1;33(10):1619-1622. doi: 10.1097/QAD.0000000000002260.
- Derived from this study: PubMed 30816632Kiweewa FM, Brown E, Mishra A, Nair G, Palanee-Phillips T, Mgodi N, Nakabiito C, Chakhtoura N, Hillier SL, Baeten JM; MTN-020/ASPIRE Study Team. Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women. J Int AIDS Soc. 2019 Feb;22(2):e25257. doi: 10.1002/jia2.25257.
- Derived from this study: PubMed 30346511Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis. 2019 Jul 18;69(3):523-529. doi: 10.1093/cid/ciy909.
- Derived from this study: PubMed 30218318Mensch BS, Richardson BA, Husnik M, Brown ER, Kiweewa FM, Mayo AJ, Baeten JM, Palanee-Phillips T, van der Straten A; MTN-020/ASPIRE study team. Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE. AIDS Behav. 2019 Feb;23(2):504-512. doi: 10.1007/s10461-018-2261-8.
- Derived from this study: PubMed 26900902Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM, Matovu Kiweewa F, Nair G, Mhlanga F, Siva S, Bekker LG, Jeenarain N, Gaffoor Z, Martinson F, Makanani B, Pather A, Naidoo L, Husnik M, Richardson BA, Parikh UM, Mellors JW, Marzinke MA, Hendrix CW, van der Straten A, Ramjee G, Chirenje ZM, Nakabiito C, Taha TE, Jones J, Mayo A, Scheckter R, Berthiaume J, Livant E, Jacobson C, Ndase P, White R, Patterson K, Germuga D, Galaska B, Bunge K, Singh D, Szydlo DW, Montgomery ET, Mensch BS, Torjesen K, Grossman CI, Chakhtoura N, Nel A, Rosenberg Z, McGowan I, Hillier S; MTN-020-ASPIRE Study Team. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2121-2132. doi: 10.1056/NEJMoa1506110. Epub 2016 Feb 22.
- Individual participant dataSharing planned: No
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HIV, Substance Use Disorder
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.
Jared Baeten, MD, PhD study chair
International Clinical Research Center, Department of Global Health, University of Washington
Thesla Palanee, PhD study chair
Wits Reproductive Health and HIV Institute (WRHI), Research Centre
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapivirine Vaginal Ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 7 sites in 4 countries.
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 7 inclusion and 34 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, Malawi, Uganda, Zimbabwe. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. (time frame: minimum of 12 months and a maximum of 14 months per participant). The study lists 2 primary outcomes in all. 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 NCT01617096, which also lists 9 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 21 Dec 2022.