HIV InfectionsPhase 1NCT00446979
Safety Study of UC-781 Vaginal Microbicide
A Phase 1 study testing UC 781 in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Thailand.
Trial summary
This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- UC 781
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2007to Oct 2007
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years old
- Regular menses
- HIV-1 seronegative at screening
- Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
- No evidence of reproductive tract infection (RTI)
- Willing and able to comply with study procedures, including pelvic exams, colposcopy, maintaining a study coital and symptom log, and applying assigned study gel per protocol
Show all 24Show fewer
- Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
- Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
- Insertion of fingers and other objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels, including douches, lubricants, or feminine hygiene products
- In a monogamous sexually active relationship with one male partner
- Report having vaginal intercourse only with that partner at least two times per week
- No other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Agree to use condoms for each act of vaginal intercourse during participation in the study
- Their male partner is informed and also consents to participate in the study
- Willing to have male partner informed and treated if an STD is diagnosed at screening or during the study
- Age 18 years or older
- HIV-seronegative and free of other STI at screening exam
- One female sexual partner; no other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Willing and able to comply with study procedures, including clinic visits, interviews and acceptability evaluation, and consistent use of condoms during enrollment in the study
- Willing to have female partner informed and treated if an STD is diagnosed at screening or during the study
Who cannot join
- Pregnancy or desire to become pregnant at time of study participation
- Currently breastfeeding
- Delivery or abortion within last eight weeks
- History of any male sexual partner other than current partner in past six months
- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
- History of post-coital vaginal bleeding in the past three months
Show all 17Show fewer
- History of surgery to remove uterus or cervix
- History of surgery on the external genitalia, vaginal, or cervix in the past month
- Clinically significant chronic medical condition that is considered progressive, including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
- History of sensitivity/allergy to latex
- Existence of a clinically detectable genital abnormality at screening (e.g. ulcer, congenital abnormality, any lesion with mucosal disruption)
- Concurrent participation in another trial of a vaginal product
- Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
- History of genital surgery in the past month
- Clinical or laboratory evidence of an STI.
- History of sensitivity/allergy to latex
- History of any sexual partner other than their current partner in the past six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand
This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.
- Conditions
- HIV Infections
- Being tested
- Placebo gel, UC 781
- Keywords
- Microbicides, 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.
Placebo gelDrug
HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
UC 781Drug
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | UC 781 0.1% carbomer gel Receives: Drug: UC 781 |
| 2 | Experimental | UC 781 0.25% carbomer gel Receives: Drug: UC 781 |
| 3 | Placebo comparator | Placebo vaginal gel Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
Measured: 2 weeks
Symptoms of irritation
Measured: two weeks
Changes in vaginal flora
Measured: Two weeks
Assessment of pro-inflammatory cytokines in the genital tract
Measured: Two weeks
Other product-related adverse events
Measured: Two weeks
Secondary outcomes (3)
acceptability of UC-781 gel use
Measured: Two weeks
systemic absorption of UC-781
Measured: Two weeks
anti-HIV activity of genital secretions in the presence of UC-781 gel
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJun 2007
- Study completionOct 2007
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Thailand, CONRAD
- Responsible party
- Sponsor
- Investigators
- Sara J Whitehead, MD, MPH, Principal investigator, Centers for Disease Control and PreventionChitlada Utaipiboon, MD, Principal investigator, Thailand MOPH - U.S. CDC Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446979
- Sponsor's protocol ID
- CDC-NCHHSTP-4744
- Other IDs
- MOPH 109/2548
- Status last verified
- Apr 2013
- First submitted
- 12 Mar 2007
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand
- ClinicalTrials.gov ID
- NCT00446979
- Acronym / sponsor ID
- CDC-NCHHSTP-4744
- Conditions
- HIV Infections
- Keywords
- Microbicides, HIV seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Thailand, CONRAD
- Study start
- Jun 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 13 Mar 2007 (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 help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: UC 781UC 781 0.1% carbomer gel |
| 2 | Experimental | Drug: UC 781UC 781 0.25% carbomer gel |
| 3 | Placebo comparator | Drug: Placebo gelPlacebo vaginal gel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Age 18-50 years old
- Regular menses
- HIV-1 seronegative at screening
- Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
- No evidence of reproductive tract infection (RTI)
Key exclusion criteria (17 listed)
- Pregnancy or desire to become pregnant at time of study participation
- Currently breastfeeding
- Delivery or abortion within last eight weeks
- History of any male sexual partner other than current partner in past six months
- History of post-coital vaginal bleeding in the past three months
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 |
|---|---|---|
| Placebo gelHEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks | Drug | 3 |
| UC 781UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks | Drug | 1, 2 |
Primary outcome
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
Time frame: 2 weeks
Symptoms of irritation
Time frame: two weeks
Changes in vaginal flora
Time frame: Two weeks
Assessment of pro-inflammatory cytokines in the genital tract
Time frame: Two weeks
Other product-related adverse events
Time frame: Two weeks
3 secondary outcomes
acceptability of UC-781 gel use
Time frame: Two weeks
systemic absorption of UC-781
Time frame: Two weeks
anti-HIV activity of genital secretions in the presence of UC-781 gel
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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.
Sara J Whitehead, MD, MPH principal investigator
Centers for Disease Control and Prevention
Chitlada Utaipiboon, MD principal investigator
Thailand MOPH - U.S. CDC Collaboration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UC 781 in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Thailand.
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 24 inclusion and 17 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 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines (time frame: 2 weeks). The study lists 5 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 19 Apr 2013.