HIV-1 InfectionsPhase 1/2NCT00799058
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A Phase 1/2 study testing dapivirine 4789 and dapivirine gel 4759 in people with HIV-1 Infections, run by International Partnership for Microbicides, Inc. at 5 sites in United States.
Trial summary
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Infections
- What is being tested?
- dapivirine 4789 and dapivirine gel 4759
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jul 2009to 8 Jan 2011
- Phase
- Phase 1/2
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Healthy and self-reported sexually active
- HIV-negative as determined by an HIV test at time of enrollment
- Willing to be on a stable form of contraception
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle
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- Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff
- Asymptomatic for genital infections at the time of enrollment
- Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.
- Documentation of no abnormality on Pap smear within 90 days prior to randomization;
- Willing to answer acceptability and adherence questionnaires throughout the trial
- Willing to refrain from participation in any other research trial for the duration of this trial
- Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures
- Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit:
- Vaginal intercourse
- Oral contact with her genitalia
- Internal vaginal washing
- Penetration of the vagina by fingers, sex toys, or any other objects, including medications
- Willing to abstain from all of the following for 3 days after biopsy procedures:
- Vaginal intercourse
- Oral contact with her genitalia
- Internal vaginal washing
- Penetration of the vagina by fingers, sex toys, or any other objects, including medications
Who cannot join
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding, or having breastfed within 3 months prior to screening
- Receipt of any investigational agent within 60 days prior to screening
- Previously participated in any HIV vaccine trial
- Untreated urogenital infections within 2 weeks prior to enrollment
- Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
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- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction
- Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection)
- History of symptomatic or asymptomatic HSV-2
- Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline
- Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
- Any serious acute, chronic or progressive disease
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)
Birmingham, Alabama, 35294
University of Illinois at Chicago
Chicago, Illinois, 60612
Albert Einstein College of Medicine
New York, New York, 10461
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women
Read the detailed description
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.
- Conditions
- HIV-1 Infections
- Being tested
- dapivirine 4789, dapivirine gel 4759, Drug placebo
- Keywords
- HIV-1 infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirine 4789Drug
Also called TMC120
dapivirine gel 4789, 0.05%, 2.5g applied once daily
dapivirine gel 4759Drug
Also called TMC120
dapivirine gel 4759, 0.05%, 2.5g applied once daily
Drug placeboDrug
Also called HEC-based placebo gel, 2.5g
HEC-based universal placebo gel, 2.5g applied once daily
| Study group | Role | What they receive |
|---|---|---|
| dapivirine gel 4789 | Active comparator | will be applied by participants once daily for 12-weeks treatment period Receives: Drug: dapivirine 4789 |
| dapivirine gel 4759 | Active comparator | Will be applied by participants once daily for12-weeks treatment period Receives: Drug: dapivirine gel 4759 |
| HEC-based placebo gel, 2.5g containing no Dapivirine | Placebo comparator | Will be applied once daily for 12-weeks treatment period Receives: Drug: Drug placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.
A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE.
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: 12 weeks
Secondary outcomes (7)
Changes in the Vaginal Flora
Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.
Nugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10).
Measured: 16 weeks
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point
Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.
Measured: 12 weeks
The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.
Measured: 12 weeks
Changes in the Vaginal pH
Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12). Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.
Measured: 12 weeks
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.
The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics. In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point. Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.
Measured: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.
The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.
Measured: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study start6 Jul 2009
- Primary completion8 Jan 2011
- Study completion8 Jan 2011
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.
- Other trials for HIV-1 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled participants will apply gel on a daily basis for 12 weeks, with clinical follow-up visits at weeks 2,4,8 and 12 to monitor safety and acceptability, and a final visit 4 weeks post gel discontinuation (Visit 6, week 16) Dapivirine concentration will be measured in blood and vaginal fluid and cervical tissue.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Annalene Nel, Study chair, International Partnership for Microbicides
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799058
- Sponsor's protocol ID
- IPM 020
- Status last verified
- Oct 2022
- First submitted
- 26 Nov 2008
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
- ClinicalTrials.gov ID
- NCT00799058
- Acronym / sponsor ID
- IPM 020
- Conditions
- HIV-1 Infections
- Keywords
- HIV-1 infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2009 (actual)
- Primary completion
- 8 Jan 2011 (actual)
- Study completion
- 8 Jan 2011 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women
Detailed description
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All enrolled participants will apply gel on a daily basis for 12 weeks, with clinical follow-up visits at weeks 2,4,8 and 12 to monitor safety and acceptability, and a final visit 4 weeks post gel discontinuation (Visit 6, week 16) Dapivirine concentration will be measured in blood and vaginal fluid and cervical tissue.
| Arm | Type | Receives |
|---|---|---|
| dapivirine gel 4789 | Active comparator | Drug: dapivirine 4789will be applied by participants once daily for 12-weeks treatment period |
| dapivirine gel 4759 | Active comparator | Drug: dapivirine gel 4759Will be applied by participants once daily for12-weeks treatment period |
| HEC-based placebo gel, 2.5g containing no Dapivirine | Placebo comparator | Drug: Drug placeboWill be applied once daily for 12-weeks treatment period |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Healthy and self-reported sexually active
- HIV-negative as determined by an HIV test at time of enrollment
- Willing to be on a stable form of contraception
Key exclusion criteria (14 listed)
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding, or having breastfed within 3 months prior to screening
- Receipt of any investigational agent within 60 days prior to screening
- Previously participated in any HIV vaccine trial
- Untreated urogenital infections within 2 weeks prior to enrollment
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 4789Also: TMC120dapivirine gel 4789, 0.05%, 2.5g applied once daily | Drug | dapivirine gel 4789 |
| dapivirine gel 4759Also: TMC120dapivirine gel 4759, 0.05%, 2.5g applied once daily | Drug | dapivirine gel 4759 |
| Drug placeboAlso: HEC-based placebo gel, 2.5gHEC-based universal placebo gel, 2.5g applied once daily | Drug | HEC-based placebo gel, 2.5g containing no Dapivirine |
Primary outcome
The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.
Time frame: 12 weeks
A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
7 secondary outcomes
Changes in the Vaginal Flora
Time frame: 16 weeks
The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point
Time frame: 12 weeks
The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Time frame: 12 weeks
Changes in the Vaginal pH
Time frame: 12 weeks
The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.
Time frame: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.
Time frame: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dr Annalene Nel study chair
International Partnership for Microbicides
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dapivirine 4789 and dapivirine gel 4759 in people with HIV-1 Infections, run by International Partnership for Microbicides, Inc. at 5 sites in United States.
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 23 inclusion and 14 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 25 Oct 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?
The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.