HIV InfectionsPhase 1NCT00132444
Study of UC-781 Vaginal Microbicide
A Phase 1 study testing topical vaginal application of UC-781 gel in people with HIV Infections, run by CONRAD at 1 site in United States.
Trial summary
This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- topical vaginal application of UC-781 gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For All Females:
- Ages 18-45 years of age
- Able to provide written informed consent
- Normal Pap smear at screening or documentation of such within six months prior
- Regular monthly menses or amenorrhea due to hormonal contraceptive use
- Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol
Show all 34Show fewer
- Able/willing to complete Study Diary
- Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit
- Agree to apply assigned study gel as required per protocol
- Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
- Insertion of fingers/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
- Participating in other vaginal microbicide or contraceptive studies
- Additional Inclusion Criteria for Stage 1:
- HIV-uninfected
- In a monogamous sexually active relationship with one male partner throughout the study
- Report having vaginal intercourse only with that partner at least two times per week
- Agree to use study-provided male condoms for each act of vaginal intercourse while taking part in the study
- Agree to inform male partner about participation
- Additional Inclusion Criteria for Stage 2:
- HIV-infected
- Sexually abstinent or agree to abstain from sexual intercourse while taking part in the study
- Under regular medical care for HIV management
- CD4+ lymphocyte count > 200/mm3 for the last 6 months
- HIV viral load > 4.0 log10 copies/ml at screening
- Documentation of prior HIV genotype with one or more mutations conferring resistance to a non-nucleoside reverse transcriptase inhibitor (NNRTI)
- Not currently on antiretrovirals
- Willing to provide study staff with access to medical records related to their HIV infection
- Ages 18 years or older
- Able to give written informed consent
- Male sexual partners of HIV-uninfected women taking part in Stage 1 of the study
Who cannot join
- Are post-menopausal
- Have had a hysterectomy
- Clinically significant chronic medical condition (other than HIV) that is considered progressive.
- History of malignancy, with the exception of basal cell or squamous cell skin cancer
- Pregnant or planning to become pregnant in the next three months
- Currently breastfeeding
Show all 40Show fewer
- History of sensitivity or allergy to latex or any compound used in this study
- Have received antibiotics in the 14 days prior to enrollment
- Have used a spermicide or spermicidally lubricated condom within 7 days prior to enrollment
- Have been using a hormonal contraceptive method for less than 3 months prior to enrollment
- Have participated in other microbicide or contraceptive studies in the past three months
- Grade 3 or higher liver, renal or hematology abnormality, as defined by the Table for Grading the Severity of Adult Adverse Events at screening
- Have a positive bacterial urine culture
- Currently have a clinically detectable genital abnormality (i.e. vulvar, vaginal, cervical and/or perineal ulcer or lesions or abnormal Pap smear)
- In the three months prior to enrollment have had any of the following:
- An abnormal Pap smear
- A pregnancy
- An abortion
- An intrauterine device (IUD)
- Breakthrough menstrual bleeding
- Vaginal bleeding during or following vaginal intercourse
- Gynecologic surgery
- Signs consistent with a sexually transmitted disease (STD)
- Signs of genital trauma
- Signs of genital tract infection other than asymptomatic bacterial vaginosis (BV)
- In the six months prior to enrollment have had any of the following:
- History of treatment for or a diagnosis with a new STD
- Exchanged sex for money, drugs or gifts
- Protected (with condoms) penile-vaginal or penile-anal sexual contact with more than 4 partners
- Unprotected (without condoms) penile-vaginal or penile-anal sexual contact with more than 1 partner
- A male sexual partner who was diagnosed or treated for an STD (other than HIV)
- A male sexual partner who has injected drugs
- Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), crack or other recreational drugs
- Are currently abusing, or in the last year have abused alcohol.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Additional Exclusion Criteria for Stage 1:
- Unprotected (without condoms) or protected (with condoms) penile-vaginal or penile-anal sexual contact with an HIV-infected partner in the past 6 months
- Unwilling to use study-provided male condoms while on study
- Additional Exclusion Criteria for Stage 2:
- NNRTI mutations in plasma and/or genital secretions at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Clinic of Emory University
Decatur, Georgia, 30030
About this study
Official title: Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Heterosexual Women and Their Male Partners
This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.
Read the detailed description
Purpose: To assess the safety and acceptability of vaginal use of 0.1% and 0.25% UC-781 gel in sexually active HIV-uninfected women, and their male partners, and sexually abstinent HIV-infected women
Design: Single-center, phase I randomized, double-blind, controlled trial with 14 days of twice-daily product or control gel exposure
Study population: Sexually active, HIV-uninfected women at low-risk for HIV and their male partners; sexually-abstinent HIV-infected women; all age 18-45
Size: 36 sexually active HIV-uninfected women and up to 36 of their male partners; 18 sexually abstinent HIV-infected women
Treatment regimen:
Stage 1: HIV-uninfected, sexually active women and 1 male partner per woman:
12 women assigned to 0.1% UC-781 twice daily x 14 days; 12 women assigned to 0.25% UC-781 twice daily x 14 days; 12 women assigned to control gel twice daily X 14 days.
Stage 2: HIV-infected, abstinent women: 12 assigned to 0.25% UC-781 twice daily x 14 days; 6 assigned to control gel twice daily x 14 days
Study duration: Participant accrual will take 6 months. Each participant will be followed for 14 days in Stage 1 and 21 days in Stage 2. Total study duration will be 9 months.
Study Site: The Hope Clinic of Emory University, Decatur, GA
Primary Objectives:
- To assess the safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually active HIV-uninfected women
- To assess the safety and toxicity of 0.25% UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually abstinent HIV-infected women
Secondary Objectives:
- To assess the acceptability of 0.1% and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days among HIV-uninfected, and the acceptability of 0.25% gel similarly administered to HIV-infected women
- To assess the effect of study product on vaginal microflora of HIV-uninfected and HIV-infected women
- To assess the systemic absorption of 0.1% and 0.25% UC-781 gel when administered intravaginally
- To assess HIV viral load in genital secretions in HIV-infected women during 0.25% UC-781 gel use
- To assess the genotypic resistance patterns of HIV in genital secretions and peripheral blood in HIV-infected women during 0.25% UC-781 gel use
- To assess the acceptability of 0.1% and 0.25% UC-781 gel in male sexual partners of HIV-uninfected women
Primary Endpoints:
The safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days in sexually-active HIV-uninfected women and 0.25% UC-781 gel administered in sexually-abstinent HIV-infected women will be assessed by:
- Macroscopic and/or microscopic evidence of vulvar and/or vaginal epithelium damage, including ulceration, abrasion, severe erythema, and/or severe edema
- Macroscopic and/or microscopic evidence of cervical mucosal damage including ulceration, abrasion, severe erythema, and/or severe edema
- Symptoms of genital irritation, including burning, itching or soreness
- Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause
Secondary Endpoints:
Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and 0.25% UC-781 gel use by HIV-infected women will be assessed by:
- Proportion of participants who at Day 14 visit indicate they would be 'somewhat unlikely' or 'very unlikely' to use 0.1% and 0.25% UC-781 gel during sexual intercourse in the future compared to control gel users
- Reported positive aspects of using 0.1% and 0.25% UC-781 gel compared to control gel users
- Reported negative aspects of using 0.1% and 0.25% UC-781 gel compared to control gel users
- Conditions
- HIV Infections
- Being tested
- topical vaginal application of UC-781 gel
- Keywords
- HIV, topical microbicides
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical vaginal application of UC-781 gelDrug
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 0.25% gel Receives: Drug: topical vaginal application of UC-781 gel |
| 2 | Active comparator | 0.1% gel Receives: Drug: topical vaginal application of UC-781 gel |
| 3 | Placebo comparator | Not described Receives: Drug: topical vaginal application of UC-781 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema.
Measured: with two weeks of administration
Symptoms of genital irritation, including burning, itching or soreness
Measured: With 2 weeks of administration
Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause
Measured: with 2 weeks of administration
Secondary outcomes (1)
Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and HIV-infected women
Measured: queried after 2 weeks of administation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Centers for Disease Control and Prevention
- Investigators
- Kimberly Workowski, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132444
- Sponsor's protocol ID
- CDC-NCHSTP-4413
- Status last verified
- Jan 2010
- First submitted
- 11 Jul 2005
- Last updated
- 7 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. 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 Heterosexual Women and Their Male Partners
- ClinicalTrials.gov ID
- NCT00132444
- Acronym / sponsor ID
- CDC-NCHSTP-4413
- Conditions
- HIV Infections
- Keywords
- HIV, topical microbicides
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- Emory University, Centers for Disease Control and Prevention
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Aug 2005 (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 the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.
Detailed description
Purpose: To assess the safety and acceptability of vaginal use of 0.1% and 0.25% UC-781 gel in sexually active HIV-uninfected women, and their male partners, and sexually abstinent HIV-infected women
Design: Single-center, phase I randomized, double-blind, controlled trial with 14 days of twice-daily product or control gel exposure
Study population: Sexually active, HIV-uninfected women at low-risk for HIV and their male partners; sexually-abstinent HIV-infected women; all age 18-45
Size: 36 sexually active HIV-uninfected women and up to 36 of their male partners; 18 sexually abstinent HIV-infected women
Treatment regimen:
Stage 1: HIV-uninfected, sexually active women and 1 male partner per woman:
12 women assigned to 0.1% UC-781 twice daily x 14 days; 12 women assigned to 0.25% UC-781 twice daily x 14 days; 12 women assigned to control gel twice daily X 14 days.
Stage 2: HIV-infected, abstinent women: 12 assigned to 0.25% UC-781 twice daily x 14 days; 6 assigned to control gel twice daily x 14 days
Study duration: Participant accrual will take 6 months. Each participant will be followed for 14 days in Stage 1 and 21 days in Stage 2. Total study duration will be 9 months.
Study Site: The Hope Clinic of Emory University, Decatur, GA
Primary Objectives:
- To assess the safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually active HIV-uninfected women
- To assess the safety and toxicity of 0.25% UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually abstinent HIV-infected women
Secondary Objectives:
- To assess the acceptability of 0.1% and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days among HIV-uninfected, and the acceptability of 0.25% gel similarly administered to HIV-infected women
- To assess the effect of study product on vaginal microflora of HIV-uninfected and HIV-infected women
- To assess the systemic absorption of 0.1% and 0.25% UC-781 gel when administered intravaginally
- To assess HIV viral load in genital secretions in HIV-infected women during 0.25% UC-781 gel use
- To assess the genotypic resistance patterns of HIV in genital secretions and peripheral blood in HIV-infected women during 0.25% UC-781 gel use
- To assess the acceptability of 0.1% and 0.25% UC-781 gel in male sexual partners of HIV-uninfected women
Primary Endpoints:
The safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days in sexually-active HIV-uninfected women and 0.25% UC-781 gel administered in sexually-abstinent HIV-infected women will be assessed by:
- Macroscopic and/or microscopic evidence of vulvar and/or vaginal epithelium damage, including ulceration, abrasion, severe erythema, and/or severe edema
- Macroscopic and/or microscopic evidence of cervical mucosal damage including ulceration, abrasion, severe erythema, and/or severe edema
- Symptoms of genital irritation, including burning, itching or soreness
- Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause
Secondary Endpoints:
Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and 0.25% UC-781 gel use by HIV-infected women will be assessed by:
- Proportion of participants who at Day 14 visit indicate they would be 'somewhat unlikely' or 'very unlikely' to use 0.1% and 0.25% UC-781 gel during sexual intercourse in the future compared to control gel users
- Reported positive aspects of using 0.1% and 0.25% UC-781 gel compared to control gel users
- Reported negative aspects of using 0.1% and 0.25% UC-781 gel compared to control gel users
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: topical vaginal application of UC-781 gel0.25% gel |
| 2 | Active comparator | Drug: topical vaginal application of UC-781 gel0.1% gel |
| 3 | Placebo comparator | Drug: topical vaginal application of UC-781 gel |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (34 listed)
- Ages 18-45 years of age
- Able to provide written informed consent
- Normal Pap smear at screening or documentation of such within six months prior
- Regular monthly menses or amenorrhea due to hormonal contraceptive use
- Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol
Key exclusion criteria (40 listed)
- Are post-menopausal
- Have had a hysterectomy
- Clinically significant chronic medical condition (other than HIV) that is considered progressive.
- History of malignancy, with the exception of basal cell or squamous cell skin cancer
- Pregnant or planning to become pregnant in the next 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 |
|---|---|---|
| topical vaginal application of UC-781 gelUC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days | Drug | 1, 2, 3 |
Primary outcome
Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema.
Time frame: with two weeks of administration
Symptoms of genital irritation, including burning, itching or soreness
Time frame: With 2 weeks of administration
Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause
Time frame: with 2 weeks of administration
1 secondary outcome
Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and HIV-infected women
Time frame: queried after 2 weeks of administation
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 7 Jan 2010.
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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.
Kimberly Workowski, MD principal investigator
Emory University
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 topical vaginal application of UC-781 gel in people with HIV Infections, run by CONRAD at 1 site 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 34 inclusion and 40 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 7 Jan 2010. 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 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 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?
Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema. (time frame: with two weeks of administration). The study lists 3 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 7 Jan 2010.