HIV InfectionsPhase 1NCT01242579
A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium
A Phase 1 study testing Maraviroc/Dapivirine Gel, Dapivirine Vaginal Gel and Maraviroc Vaginal Gel in people with HIV Infections, run by International Partnership for Microbicides, Inc..
Trial summary
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc gel and determine whether it is safe for daily use by healthy women in the United Kingdom 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 Infections
- What is being tested?
- Maraviroc/Dapivirine Gel, Dapivirine Vaginal Gel and Maraviroc Vaginal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2011
- Phase
- Phase 1
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to40 years of age who can give written informed consent (illiterate participants may provide a thumbprint or mark witnessed and signed by a person independent from trial staff);
- Available for all visits and consent to follow all procedures scheduled for the trial;
- HIV-negative as determined by an HIV test at time of enrollment;
- Be on a stable form of contraception, defined as:
- A stable oral contraceptive regimen for at least 2 months prior to enrollment, OR,
- Transdermal contraceptive patch for at least 3 months prior to enrollment, OR,
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- Long-acting progestins for at least 6 months prior to enrollment, OR,
- An IUD inserted (with no vaginal or gynaecological complaints associated with its use) at least 3 months prior to enrolment, OR,
- Have undergone surgical sterilization at least 3 months prior to enrollment;
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses;
- Upon pelvic examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the Investigator;
- Asymptomatic for genital infections at the time of enrollment (if a woman is diagnosed with any treatable STI, either syndromically or by laboratory test at the time of screening, she must receive treatment at least 2 weeks prior to enrollment and have completed treatment);
- Willing to refrain from the use of vaginal products or objects including, tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for 14 days prior to enrollment and for the duration of the trial;
- Willing to use oral contraceptives to avoid menstruation, if necessary, while taking part in this trial;
- Documentation of no abnormality on Pap test, including grossly bloody smear, within 3 months prior to screening;
- 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 [e.g., by home visit or telephone; or via family or close neighbour contacts (confidentiality to be maintained)];
- Willing to agree to abstain from oral contact with her genitalia for gel use period, as well as for a total of 3 days (72 hours) after the biopsy procedure:
- Willing to remain sexually abstinent for the gel use period in this trial;
- Hepatitis B and C negative at the time of enrollment.
Who cannot join
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening;
- Currently breast-feeding;
- Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening;
- Untreated symptomatic urogenital infections, e.g., urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment;
- Presence of any abnormal clinically significant physical finding on the vulva, vaginal walls or cervix during pelvic examination and/or colposcopy at pre-enrolment;
- History of urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence;
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- Current vulvar or vaginal symptoms/abnormalities that could influence the trial results;
- Pap test result that requires cryotherapy, biopsy, treatment (other than for infection); or further evaluation [this includes any findings of atypical squamous cells of undetermined significance (ASCUS)];
- Symptomatic genital HSV infection or a history of genital herpetic infection;
- Any Grade 2, 3 or 4 haematology, chemistry or urinalysis laboratory abnormality at baseline (screening) according to the DAIDS Table for Grading Adverse Events (NOTE: This table can be found at: http://rcc.tech-res.com/safetyandpharmacovigilance;and a standardized version will be provided to the research centre in the Study Operations Manual);
- Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic 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 or silicone;
- Any serious acute, chronic or progressive disease (e.g., any known history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition;
- Have undergone a hysterectomy;
- History of drug abuse within 1 year of enrollment;
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
About this study
Official title: A Double-Blind, Randomised, Placebo-Controlled Phase I Trial to Compare the Pharmacokinetics of Maraviroc and Dapivirine Following Application of Maraviroc Vaginal Vaginal Gel, 0.1% 2.5g, Dapivirine Vaginal Gel, 0.05%, 2.5g and Maraviroc 0.1% + Dapivirine 0.05% Vaginal Gel, 2.5g Formulations, and to Assess Their Safety as Compared to the Matching Placebo Vaginal Gel, 2.5g in Healthy, HIV-Negative Women
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc gel and determine whether it is safe for daily use by healthy women in the United Kingdom
- Conditions
- HIV Infections
- Being tested
- Maraviroc/Dapivirine Gel, Dapivirine Vaginal Gel, Maraviroc Vaginal Gel, Matching Placebo Gel
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maraviroc/Dapivirine GelDrug
Vaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05%
Dapivirine Vaginal GelDrug
Dapivirine vaginal gel containing 2.5g
Maraviroc Vaginal GelDrug
Maraviroc vaginal gel containing 2.5g
Matching Placebo GelDrug
Matching placebo gel containing 2.5g
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc Vaginal Gel | Active comparator | Drug: Maraviroc dosage form: vaginal gel dosage: 2.5g frequency: once daily duration: 11 days Receives: Drug: Maraviroc Vaginal Gel |
| Dapivirine Vaginal Gel | Active comparator | Drug: Dapivirine dosage form: vaginal gel dosage: 2.5g dapivirine frequency: once daily duration: 11 days Receives: Drug: Dapivirine Vaginal Gel |
| Matching Placebo Gel | Placebo comparator | Drug: placebo dosage form: vaginal gel dosage: 2.5g placebo frequency: once daily duration: 11 days Receives: Drug: Matching Placebo Gel |
| Maraviroc/Dapivirine Gel | Experimental | Drug: Maraviroc/Dapivirine dosage form: combination vaginal gel dosage: 2.5g - Maraviroc 0.1%, Dapivirine 0.05% frequency: once daily duration: 11 days Receives: Drug: Maraviroc/Dapivirine Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To assess the safety and tolerability of the combination maraviroc and dapivirine gel, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description).
- Mucosal abnormalities (as defined in the WHO/CONRAD manual) visible during naked eye examination and/or colposcopy;
- Abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial;
- Positive diagnostic tests for trichomonas, gonorrhoea and/or chlamydia;
- At least one adverse event during the 2 month trial period;
- Any laboratory abnormalities on haematology, electrolytes, liver function, and renal function.
Measured: 8 weeks
Pharmacokinetics: assessment of local and systemic pharmacokinetics of maraviroc and dapivirine in plasma, vaginal fluid and cervical tissue before, during and after 11 days.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: In order to focus efforts on the combination ring formulation, IPM decided not to move forward with this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242579
- Sponsor's protocol ID
- IPM 025
- Status last verified
- Sep 2011
- First submitted
- 15 Nov 2010
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-Controlled Phase I Trial to Compare the Pharmacokinetics of Maraviroc and Dapivirine Following Application of Maraviroc Vaginal Vaginal Gel, 0.1% 2.5g, Dapivirine Vaginal Gel, 0.05%, 2.5g and Maraviroc 0.1% + Dapivirine 0.05% Vaginal Gel, 2.5g Formulations, and to Assess Their Safety as Compared to the Matching Placebo Vaginal Gel, 2.5g in Healthy, HIV-Negative Women
- ClinicalTrials.gov ID
- NCT01242579
- Acronym / sponsor ID
- IPM 025
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In order to focus efforts on the combination ring formulation, IPM decided not to move forward with this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Nov 2010 (estimated)
- 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.
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc gel and determine whether it is safe for daily use by healthy women in the United Kingdom
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maraviroc Vaginal Gel | Active comparator | Drug: Maraviroc Vaginal GelDrug: Maraviroc dosage form: vaginal gel dosage: 2.5g frequency: once daily duration: 11 days |
| Dapivirine Vaginal Gel | Active comparator | Drug: Dapivirine Vaginal GelDrug: Dapivirine dosage form: vaginal gel dosage: 2.5g dapivirine frequency: once daily duration: 11 days |
| Matching Placebo Gel | Placebo comparator | Drug: Matching Placebo GelDrug: placebo dosage form: vaginal gel dosage: 2.5g placebo frequency: once daily duration: 11 days |
| Maraviroc/Dapivirine Gel | Experimental | Drug: Maraviroc/Dapivirine GelDrug: Maraviroc/Dapivirine dosage form: combination vaginal gel dosage: 2.5g - Maraviroc 0.1%, Dapivirine 0.05% frequency: once daily duration: 11 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Women 18 to40 years of age who can give written informed consent (illiterate participants may provide a thumbprint or mark witnessed and signed by a person independent from trial staff);
- Available for all visits and consent to follow all procedures scheduled for the trial;
- HIV-negative as determined by an HIV test at time of enrollment;
- Be on a stable form of contraception, defined as:
- A stable oral contraceptive regimen for at least 2 months prior to enrollment, OR,
Key exclusion criteria (16 listed)
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening;
- Currently breast-feeding;
- Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening;
- Untreated symptomatic urogenital infections, e.g., urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment;
- Presence of any abnormal clinically significant physical finding on the vulva, vaginal walls or cervix during pelvic examination and/or colposcopy at pre-enrolment;
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 |
|---|---|---|
| Maraviroc/Dapivirine GelVaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05% | Drug | Maraviroc/Dapivirine Gel |
| Dapivirine Vaginal GelDapivirine vaginal gel containing 2.5g | Drug | Dapivirine Vaginal Gel |
| Maraviroc Vaginal GelMaraviroc vaginal gel containing 2.5g | Drug | Maraviroc Vaginal Gel |
| Matching Placebo GelMatching placebo gel containing 2.5g | Drug | Matching Placebo Gel |
Primary outcome
Safety: To assess the safety and tolerability of the combination maraviroc and dapivirine gel, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description).
Time frame: 8 weeks
* Mucosal abnormalities (as defined in the WHO/CONRAD manual) visible during naked eye examination and/or colposcopy; * Abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial; * Positive diagnostic tests for trichomonas, gonorrhoea and/or chlamydia; * At least one adverse event during the 2 month trial period; * Any laboratory abnormalities on haematology, electrolytes, liver function, and renal function.
Pharmacokinetics: assessment of local and systemic pharmacokinetics of maraviroc and dapivirine in plasma, vaginal fluid and cervical tissue before, during and after 11 days.
Time frame: 8 weeks
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 9 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maraviroc/Dapivirine Gel, Dapivirine Vaginal Gel and Maraviroc Vaginal Gel in people with HIV Infections, run by International Partnership for Microbicides, Inc..
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 20 inclusion and 16 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 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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: To assess the safety and tolerability of the combination maraviroc and dapivirine gel, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description). (time frame: 8 weeks). 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?
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 9 Sep 2011.