HIV InfectionsPhase 1NCT00385554
Botswana Study of UC-781 Vaginal Microbicide
A Phase 1 study testing UC-781 carbomer gel, 0.1% and 0.25% in people with HIV Infections, run by Centers for Disease Control and Prevention at 3 sites in 2 countries.
Trial summary
This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- UC-781 carbomer gel, 0.1% and 0.25%
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Start not givento not given
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-45 years old
- citizen of Botswana
- willing to use condoms for 14 days
- PAP smear (normal, inflammation, ASCUS)
- regular menses or amenorrhea
- lives within 1 hour of a study clinic
- pass comprehension test
- provide written informed consent
Who cannot join
- genital mucosal disruption at screening
- genital surgery within past 8 weeks
- pregnant within past 8 weeks
- currently breastfeeding
- prior hysterectomy
- plans to move within 2 months
Show all 12Show fewer
- ALT, AST, total bilirubin, or creatinine Grade 2 or above
- Prothrombin or partial thromboplastin time Grade 2 or above
- In other drug/vaccine safety trial
- Has more than one sexual partner in past month
- Unwilling/unsure they can have sex at least twice weekly for 2 weeks
- Any other condition that investigator believes will interfere with the evaluation of study objectives
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
CONRAD
Arlington, Virginia, 22209
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
About this study
Official title: Phase I Trial of the Safety, Toxicity, and Acceptability of the Microbicide UC-781 When Topically Applied by HIV-uninfected Women and Men in Botswana
This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.
Read the detailed description
45 women and 45 men, all healthy and sexually active, 21-45 years old, without HIV infection, will be enrolled in Francistown and Gaborone, Botswana. Volunteers will be randomized to receive either 0.1% or 0.25% UC-781 carbomer gel or placebo gel (3 arms. Women will be instructed to apply gel intravaginally, morning and evening, and prior to sex (always with male condom use) for 14 consecutive days. Men will be instructed to apply gel topically for 14 consecutive nights, before bed, allow to dry overnight, and wash it off in the morning. Additionally instructed never to use gel during sex but always to use condoms. Volunteers will be seen weekly for evaluation of symptoms, laboratory toxicities, genital exam findings (with colposcopy for women, and plasma drug levels. Acceptability will be assessed in focus groups in the month after completing gel use.
- Conditions
- HIV Infections
- Being tested
- UC-781 carbomer gel, 0.1% and 0.25%
- Keywords
- Microbicide, HIV prevention, Botswana, Preventing acquisition of HIV infection, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-781 carbomer gel, 0.1% and 0.25%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and toxicity of 0.1% and 0.25% UC-781 carbomer gel compared to placebo gel in HIV uninfected, sexually active women and men
Secondary outcomes (3)
Effects on vaginal microflora
Systemic absorption
Use acceptability in trial populations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
Why it stopped: Study product is no longer being considered for further development.
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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- CONRAD
- Investigators
- Dawn K Smith, MD, MPH, Principal investigator, BOTUSA/CDCChristine K Mauck, MD, MPH, Study director, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385554
- Sponsor's protocol ID
- CDC-NCHSTP 4885
- Other IDs
- BOTUSA MB05
- Status last verified
- Aug 2012
- First submitted
- 5 Oct 2006
- Last updated
- 16 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of the Safety, Toxicity, and Acceptability of the Microbicide UC-781 When Topically Applied by HIV-uninfected Women and Men in Botswana
- ClinicalTrials.gov ID
- NCT00385554
- Acronym / sponsor ID
- CDC-NCHSTP 4885
- Conditions
- HIV Infections
- Keywords
- Microbicide, HIV prevention, Botswana, Preventing acquisition of HIV infection, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study product is no longer being considered for further development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- CONRAD
- First posted
- 9 Oct 2006 (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.
This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.
Detailed description
45 women and 45 men, all healthy and sexually active, 21-45 years old, without HIV infection, will be enrolled in Francistown and Gaborone, Botswana. Volunteers will be randomized to receive either 0.1% or 0.25% UC-781 carbomer gel or placebo gel (3 arms. Women will be instructed to apply gel intravaginally, morning and evening, and prior to sex (always with male condom use) for 14 consecutive days. Men will be instructed to apply gel topically for 14 consecutive nights, before bed, allow to dry overnight, and wash it off in the morning. Additionally instructed never to use gel during sex but always to use condoms. Volunteers will be seen weekly for evaluation of symptoms, laboratory toxicities, genital exam findings (with colposcopy for women, and plasma drug levels. Acceptability will be assessed in focus groups in the month after completing gel use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 21-45 years old
- citizen of Botswana
- willing to use condoms for 14 days
- PAP smear (normal, inflammation, ASCUS)
- regular menses or amenorrhea
Key exclusion criteria (12 listed)
- genital mucosal disruption at screening
- genital surgery within past 8 weeks
- pregnant within past 8 weeks
- currently breastfeeding
- prior hysterectomy
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 |
|---|---|---|
| UC-781 carbomer gel, 0.1% and 0.25% | Drug | – |
Primary outcome
The safety and toxicity of 0.1% and 0.25% UC-781 carbomer gel compared to placebo gel in HIV uninfected, sexually active women and men
3 secondary outcomes
Effects on vaginal microflora
Systemic absorption
Use acceptability in trial populations
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 16 Aug 2012.
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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.
Dawn K Smith, MD, MPH principal investigator
BOTUSA/CDC
Christine K Mauck, MD, MPH study director
CONRAD
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UC-781 carbomer gel, 0.1% and 0.25% in people with HIV Infections, run by Centers for Disease Control and Prevention at 3 sites in 2 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 8 inclusion and 12 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 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
The safety and toxicity of 0.1% and 0.25% UC-781 carbomer gel compared to placebo gel in HIV uninfected, sexually active women and men. 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 16 Aug 2012.