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CompletedNCT01617096ASPIREUpdated Dec 21, 2022Results posted

Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women

A Phase 3 interventional study of Dapivirine Vaginal Ring and Placebo Ring in HIV Infections, sponsored by International Partnership for Microbicides, Inc.. Completed at 7 sites in 4 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by International Partnership for Microbicides, Inc. (part of Population Council) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,629
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • HIV Infections
  • Anti-HIV agents
  • HIV-1
03

In context

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

This study's enrollment of 2,629 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

International Partnership for Microbicides, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 5 (38%) have results posted.

First submitted before International Partnership for Microbicides, Inc. became part of Population Council.

Browse International Partnership for Microbicides, Inc. studies →All Population Council studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 infection
  • Able and willing to provide written 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

  • 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 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 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:

    • (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)
    • 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)
    • 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,629 participants (actual)

Study arms

  • Experimental
    Dapivirine Vaginal Ring

    Vaginal ring containing 25mg dapivirine

    Combination Product: Dapivirine Vaginal Ring

  • Placebo comparator
    Placebo Ring

    Vaginal ring containing no drug substance

    Combination Product: Placebo Ring

Interventions

  • Combination productDapivirine Vaginal Ring

    Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months

  • Combination productPlacebo Ring

    Vaginal ring containing no drug substance

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: minimum of 12 months and a maximum of 14 months per participant

  2. 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

    Time frame: minimum of 12 months and a maximum of 14 months per participant

Secondary outcomes

  1. 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.

    Time frame: 12 months per participant

  2. 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?'

    Time frame: 12 months per participant

  3. 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.

    Time frame: minimum of 12 months and a maximum of 14 months per participant

07

Results

Posted Dec 16, 2022
Limitations and caveats
Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use; however, they were found to be an imperfect measure of adherence as they cannot distinguish different patterns of use during the month. In addition, self-reported adherence based on the adherence questionnaires was also considered to have limitations.

Participant flow

Participants provided written informed consent were invited to screen for the clinical trial. Each participant engaged in the screening process for up to 4 weeks (28 days) prior to enrollment. Participants who complied with inclusion and exclusion criteria were invited to enroll in the trial. Participants were randomized in a 1:1 ratio to either the Dapivirine Vaginal Ring or placebo ring group.

Participant flow — Overall Study
MilestoneDapivirine Vaginal RingPlacebo Ring
Started13131316
Completed11651179
Not completed148137
Withdrew: Withdrawal by subject9681
Withdrew: Lost to follow-up3732
Withdrew: Physician decision1018
Withdrew: Death43
Withdrew: Other13

Outcome measures

PrimaryEfficacy 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.

Time frame:
minimum of 12 months and a maximum of 14 months per participant
Reported as:
Count of participants · Participants
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.
ParticipantsDapivirine Vaginal RingPlacebo Ring
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.7197
PrimaryThe 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

Time frame:
minimum of 12 months and a maximum of 14 months per participant
Reported as:
Count of participants · Participants
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).
ParticipantsDapivirine Vaginal RingPlacebo Ring
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).12371231
SecondaryAdherence 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.

Time frame:
12 months per participant
Reported as:
Number · participants with data
Adherence to the Dapivirine Vaginal Ring.
participants with dataDapivirine Vaginal Ring
Month 1443
Month 2460
Month 3953
Month 4537
Month 5573
Month 6963
Month 7687
Month 8699
Month 9943
Month 10830
Month 11916
Month 12922
Month 13872
Month 14858
Month 15793
Month 16704
Month 17701
Month 18675
Month 19600
Month 20598
Month 21576
Month 22499
Month 23485
Month 24471
Month 25391
Month 26384
Month 27367
Month 28263
Month 29258
Month 30251
Month 31133
Month 32130
Month 33120
Month 344
SecondaryAcceptability 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?'

Time frame:
12 months per participant
Reported as:
Number · percentage of participants with data
Acceptability of the DVR and Placebo Vaginal Ring
percentage of participants with dataDapivirine Vaginal RingPlacebo Ring
Acceptability of the DVR and Placebo Vaginal Ring95.996.8
SecondaryHuman 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.

Time frame:
minimum of 12 months and a maximum of 14 months per participant
Reported as:
Count of participants · Participants
Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.
ParticipantsDapivirine Vaginal RingPlacebo Ring
Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.6896

Adverse events

Collected over 24 Months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dapivirine Vaginal Ring4/1,313 (0.3%)116/1,313 (8.8%)1,237/1,313 (94.2%)
Placebo Ring3/1,316 (0.2%)130/1,316 (9.9%)1,041/1,316 (79.1%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventDapivirine Vaginal RingPlacebo Ring
Vaginal DischargeReproductive system and breast disorders17/131320/1316
Pelvic PainReproductive system and breast disorders15/131320/1316
MetrorrhagiaReproductive system and breast disorders16/13139/1316
Vulvovaginal PruritusReproductive system and breast disorders10/131312/1316
Vulvovaginal discomfortReproductive system and breast disorders9/13135/1316
Aspartate aminotransferase increasedInvestigations4/13139/1316
Vaginal odourReproductive system and breast disorders3/13138/1316
Alanine aminotransferase increasedInvestigations3/13137/1316
Cervix erythemaReproductive system and breast disorders6/13135/1316
Neutrophil count decreasedInvestigations4/13136/1316
Most frequent other events
Showing 10 of 37
Most frequent other events
EventDapivirine Vaginal RingPlacebo Ring
MetrorrhagiaReproductive system and breast disorders723/1313732/1316
Urinary tract infectionInfections and infestations223/1313281/1316
Genitourinary chlamydia infectionInfections and infestations269/1313274/1316
MenorrhagiaReproductive system and breast disorders259/1313242/1316
Vaginal dischargeReproductive system and breast disorders179/1313174/1316
Abnormal loss of weightMetabolism and nutrition disorders173/1313175/1316
Bacterial vaginosisInfections and infestations168/1313157/1316
MenometrorrhagiaReproductive system and breast disorders160/1313148/1316
Genitourinary tract gonococcal infectionInfections and infestations143/1313160/1316
Alanine aminotransferase increasedInvestigations147/1313160/1316

Baseline characteristics

Primary safety cohort

Age, Continuous
Age, Continuous(years)Dapivirine Vaginal RingPlacebo RingTotal
Mean27.2 ± 6.0927.3 ± 6.2827.2 ± 6.18
Sex: Female, Male
Sex: Female, Male(Participants)Dapivirine Vaginal RingPlacebo RingTotal
Female131313162629
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dapivirine Vaginal RingPlacebo RingTotal
American Indian or Alaska Native000
Asian13316
Native Hawaiian or Other Pacific Islander000
Black or African American122812262454
White202
More than one race000
Unknown or Not Reported7087157
Region of Enrollment
Region of Enrollment(Participants)Dapivirine Vaginal RingPlacebo RingTotal
South Africa7137131426
Zimbabwe338340678
Malawi135137272
Uganda127126253
BMI
BMI(kg/(m^2))Dapivirine Vaginal RingPlacebo RingTotal
Mean26.8 ± 6.4127.2 ± 6.9327.0 ± 6.68
Education Status
Education Status(Participants)Dapivirine Vaginal RingPlacebo RingTotal
Less than Secondary School212192404
Secondary School and Higher110111242225
Marital Status
Marital Status(Participants)Dapivirine Vaginal RingPlacebo RingTotal
Married5275471074
Non-Married7867671553
Missing022
Has children
Has children(Participants)Dapivirine Vaginal RingPlacebo RingTotal
Count of participants118811772365

4 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • College of Medicine - Johns Hopkins University Research Project
    Blantyre, Malawi
  • UNC Project
    Lilongwe, Malawi
  • CAPRISA, eThekwini Clinical Research Site
    Durban, KwaZulu-Natal, South Africa
  • Desomond Tutu HIV Center
    Cape Town, South Africa
  • Wits Reproductive Health and HIV Institute
    Johannesburg, South Africa
  • MU-JHU Care LTD, MU-JHU Research Collaboration
    Kampala, Uganda
  • UZ-Obstetrics & Gynecology Research Clinic at Spillhaus
    Belgravia, Harare, Zimbabwe
09

References and documents

Publications

  • Browne 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 35344520 ↗
  • Leslie 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 33892693 ↗
  • Mayo 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 33713213 ↗
  • Palanee-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 31306167 ↗
  • Kiweewa 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. Erratum In: J Int AIDS Soc. 2019 Apr;22(4):e25280. doi: 10.1002/jia2.25280. PubMed 30816632 ↗
  • Riddler 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 30346511 ↗
  • Mensch 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 30218318 ↗
  • Baeten 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 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2012 to primary completion in Jul 2015, 35 months.

Results were first posted in Dec 2022, 7 years 5 months after primary completion. A results delay was requested in Feb 2017.

Of 57 industry-sponsored phase 3 interventional studies under HIV Infections, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 30. This study's 35 months is above that.

Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 20 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2012
First posted
Jun 12, 2012
StartActual
Jul 24, 2012
Primary completionActual
Jul 3, 2015
CompletionActual
Dec 2015
Results delay requested
Feb 2, 2017
Results first posted
Dec 16, 2022
Last update
Dec 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01617096
Lead sponsor
International Partnership for Microbicides, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Jun 12, 2012
Start date
Jul 24, 2012
Primary completion
Jul 3, 2015
Completion
Dec 2015
Results posted
Dec 16, 2022
Last update
Dec 21, 2022

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dapivirine

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