HIV InfectionsPhase 1NCT00441909
Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide
A Phase 1 study testing UC-781 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV uninfected
- General good health
- Normal Pap smear within 12 months prior to screen or obtained at screening visit
- Anatomy that lends itself easily to visualization of the cervix
- Sexual abstinence (including vaginal, oral, and rectal) from Visit 1 to the completion of Visit 4
- Agree to use condoms provided by the study between Visits 4 and 5
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- Agree to abstain from the use of intravaginal products or vaginal penetration throughout the study
- Willing to use acceptable forms of contraception until the completion of study
- Willing to participate in all study-related assessments and follow all study-related procedures
- Meet all inclusion criteria for the screening visit at Study Entry
- Willing to stay in the Magee-Womens Hospital Clinical Research Center (MWH CRC) for up to 9 hours after gel insertion
Who cannot join
- Menopause (at least 12 months without menses in absence of long-acting progestin use)
- Hysterectomy
- Latex allergy
- Use of a diaphragm, NuvaRing, or spermicide for contraception
- Diagnosed urogenital infection or suspected infection 21 days prior to study screening. More information on this criterion can be found in the protocol.
- Menses or other vaginal bleeding anticipated in the 17 days postscreening
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- Antibiotic or antifungal therapy (vaginal or systemic) 14 days prior to study screening
- Injected nontherapeutic drugs 12 months prior to study screening
- Systemic immunosuppressive drug use 60 days prior to study screening
- Participation in drug, spermicide, and/or microbicide study 30 days prior to study screening
- Any condition that, in the opinion of the investigator, would interfere with the study
- Intravaginal use of any device or product (except tampons) 7 days prior to study screening
- Surgical procedure involving the pelvis in the 90 days prior to enrollment (e.g., dilation and curettage or evacuation, cervical biopsy, cryosurgery,any other surgery involving pelvic organs or area)
- Abnormal pelvic exam finding that, in the opinion of the investigator would complicate interpretation of the colposcopy
- Pregnancy, or within 90 days of last pregnancy
- Breastfeeding
- Meets any of the exclusion criteria of the screening visit
- Diagnosed or suspected reproductive tract infection or urinary tract infection. More information on this criterion can be found in the protocol.
- Menses or other vaginal bleeding anticipated in the 8 days following study entry
- Injected nontherapeutic drugs between study screening and study entry
- Certain abnormal laboratory values
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
About this study
Official title: Phase I Study of the Safety and Persistence of 0.1% UC-781 Vaginal Gel in HIV-1 Seronegative Women
Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.
Read the detailed description
Vaginal microbicides are compounds applied to the inside of the vagina that may protect women against vaginal transmission of HIV and other STIs. This study will evaluate the safety of the vaginal microbicide UC-781. Studies have shown UC-781 to be an effective inhibitor of HIV-1 reverse transcriptase. UC-781 has been tested in animal models and in Phase I and II studies in humans. The results of these studies indicated that cervical tissue was fully protected from different variants of HIV. The purpose of this study is to assess the incidence of epithelial disruption and inflammation in the cervix, vagina, and vulva of healthy HIV uninfected women after a single exposure to UC-781 vaginal gel. This study will compare the results of leaving the microbicide in the vagina for varying lengths of time.
The duration of this study is approximately 35 days. Participants in this study will be randomly assigned to one of eight groups, and all participants will receive a single exposure of UC-781 or placebo gel. There will be five total study visits, including the screening and study entry visits. Screening will occur approximately 10 days prior to the study entry visit. At study entry, a single application of microbicide or placebo gel will be inserted for 0, 2, 4,or 8 hours in the vagina. Length of exposure time will differ, depending on which group a participant has been randomly assigned to. Following vaginal exposure to the microbicide, the microbicide will be rinsed off. Vaginal secretions will be collected to test antiviral activity against HIV and assess the amount of microbicide remaining in the vagina. Visits 3 through 5 occur at approximately 24 to 48 hours, 6 to 8 days, and 25 to 35 days following study entry.
At all visits, participants will be asked to complete a questionnaire and undergo a pelvic exam, STI tests, and vital signs measurements. Blood and urine collection will occur at each visit. On selected visits, a colposcopy will be conducted and participants will be interviewed regarding product acceptability, in addition to other measures. Between selected visits, participants will be asked to maintain sexual abstinence or use condoms.
- Conditions
- HIV Infections
- Being tested
- UC-781, UC-781 placebo
- Keywords
- Anti-Infective Agents, Local, Healthy Women, Microbicides, UC-781, Vaginal Gel, 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-781Drug
0.1% UC-781 Vaginal Gel
UC-781 placeboDrug
Vaginal Gel Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 8 hours Receives: Drug: UC-781 |
| 1B | Placebo comparator | Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 8 hours Receives: Drug: UC-781 placebo |
| 2A | Experimental | Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 4 hours Receives: Drug: UC-781 |
| 2B | Placebo comparator | Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 4 hours Receives: Drug: UC-781 placebo |
| 3A | Experimental | Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 2 hours Receives: Drug: UC-781 |
| 3B | Placebo comparator | Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 2 hours Receives: Drug: UC-781 placebo |
| 4A | Experimental | Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 0 hours Receives: Drug: UC-781 |
| 4B | Placebo comparator | Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 0 hours Receives: Drug: UC-781 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women
Measured: Throughout study
Secondary outcomes (6)
Persistence of UC-781 0.1% gel following a single application
Measured: At 0, 2, 4, or 8 hours post application
Systemic absorption of UC-781 following a single application of 0.1% UC-781 gel
Measured: At 0, 2, 4, or 8 hours post application
In vitro anti-HIV activity of cervicovaginal lavage fluid
Measured: Throughout study
Product acceptability
Measured: Throughout study
Measurement of vaginal flora characteristics
Measured: Throughout study
Changes in vaginal flora characteristics after a timed, single exposure
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- CONRAD
- Investigators
- Sharon L. Hillier, PhD, Principal investigator, University of PittsburghHarold C. Wiesenfeld, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441909
- Sponsor's protocol ID
- U19AI051661
- Other IDs
- U19AI051661
- Status last verified
- Mar 2009
- First submitted
- 27 Feb 2007
- Last updated
- 5 Mar 2009
- Results posted
- No
Publications
Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. doi: 10.1084/jem.20040426. Epub 2004 Apr 12. No abstract available.
PubMed 15078894Joshi S, Solomon S, Mayer K, Mehendale S. Preparing for efficacy trials of vaginal microbicides in Indian women. Indian J Med Res. 2005 Apr;121(4):502-9.
PubMed 15817959Keller MJ, Tuyama A, Carlucci MJ, Herold BC. Topical microbicides for the prevention of genital herpes infection. J Antimicrob Chemother. 2005 Apr;55(4):420-3. doi: 10.1093/jac/dki056. Epub 2005 Mar 2.
PubMed 15743896Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect. 2005 Jun;81(3):193-200. doi: 10.1136/sti.2003.007153.
PubMed 15923284Weber J, Desai K, Darbyshire J; Microbicides Development Programme. The development of vaginal microbicides for the prevention of HIV transmission. PLoS Med. 2005 May;2(5):e142. doi: 10.1371/journal.pmed.0020142. Epub 2005 May 31.
PubMed 15916473
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Persistence of 0.1% UC-781 Vaginal Gel in HIV-1 Seronegative Women
- ClinicalTrials.gov ID
- NCT00441909
- Acronym / sponsor ID
- U19AI051661
- Conditions
- HIV Infections
- Keywords
- Anti-Infective Agents, Local, Healthy Women, Microbicides, UC-781, Vaginal Gel, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- CONRAD
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 1 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.
Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.
Detailed description
Vaginal microbicides are compounds applied to the inside of the vagina that may protect women against vaginal transmission of HIV and other STIs. This study will evaluate the safety of the vaginal microbicide UC-781. Studies have shown UC-781 to be an effective inhibitor of HIV-1 reverse transcriptase. UC-781 has been tested in animal models and in Phase I and II studies in humans. The results of these studies indicated that cervical tissue was fully protected from different variants of HIV. The purpose of this study is to assess the incidence of epithelial disruption and inflammation in the cervix, vagina, and vulva of healthy HIV uninfected women after a single exposure to UC-781 vaginal gel. This study will compare the results of leaving the microbicide in the vagina for varying lengths of time.
The duration of this study is approximately 35 days. Participants in this study will be randomly assigned to one of eight groups, and all participants will receive a single exposure of UC-781 or placebo gel. There will be five total study visits, including the screening and study entry visits. Screening will occur approximately 10 days prior to the study entry visit. At study entry, a single application of microbicide or placebo gel will be inserted for 0, 2, 4,or 8 hours in the vagina. Length of exposure time will differ, depending on which group a participant has been randomly assigned to. Following vaginal exposure to the microbicide, the microbicide will be rinsed off. Vaginal secretions will be collected to test antiviral activity against HIV and assess the amount of microbicide remaining in the vagina. Visits 3 through 5 occur at approximately 24 to 48 hours, 6 to 8 days, and 25 to 35 days following study entry.
At all visits, participants will be asked to complete a questionnaire and undergo a pelvic exam, STI tests, and vital signs measurements. Blood and urine collection will occur at each visit. On selected visits, a colposcopy will be conducted and participants will be interviewed regarding product acceptability, in addition to other measures. Between selected visits, participants will be asked to maintain sexual abstinence or use condoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Drug: UC-781Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 8 hours |
| 1B | Placebo comparator | Drug: UC-781 placeboParticipants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 8 hours |
| 2A | Experimental | Drug: UC-781Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 4 hours |
| 2B | Placebo comparator | Drug: UC-781 placeboParticipants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 4 hours |
| 3A | Experimental | Drug: UC-781Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 2 hours |
| 3B | Placebo comparator | Drug: UC-781 placeboParticipants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 2 hours |
| 4A | Experimental | Drug: UC-781Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 0 hours |
| 4B | Placebo comparator | Drug: UC-781 placeboParticipants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 0 hours |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- HIV uninfected
- General good health
- Normal Pap smear within 12 months prior to screen or obtained at screening visit
- Anatomy that lends itself easily to visualization of the cervix
- Sexual abstinence (including vaginal, oral, and rectal) from Visit 1 to the completion of Visit 4
Key exclusion criteria (21 listed)
- Menopause (at least 12 months without menses in absence of long-acting progestin use)
- Hysterectomy
- Latex allergy
- Use of a diaphragm, NuvaRing, or spermicide for contraception
- Diagnosed urogenital infection or suspected infection 21 days prior to study screening. More information on this criterion can be found in the protocol.
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-7810.1% UC-781 Vaginal Gel | Drug | 1A, 2A, 3A, 4A |
| UC-781 placeboVaginal Gel Placebo | Drug | 1B, 2B, 3B, 4B |
Primary outcome
Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women
Time frame: Throughout study
6 secondary outcomes
Persistence of UC-781 0.1% gel following a single application
Time frame: At 0, 2, 4, or 8 hours post application
Systemic absorption of UC-781 following a single application of 0.1% UC-781 gel
Time frame: At 0, 2, 4, or 8 hours post application
In vitro anti-HIV activity of cervicovaginal lavage fluid
Time frame: Throughout study
Product acceptability
Time frame: Throughout study
Measurement of vaginal flora characteristics
Time frame: Throughout study
Changes in vaginal flora characteristics after a timed, single exposure
Time frame: Throughout study
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 5 Mar 2009.
- Background: PubMed 15078894Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. doi: 10.1084/jem.20040426. Epub 2004 Apr 12. No abstract available.
- Background: PubMed 15817959Joshi S, Solomon S, Mayer K, Mehendale S. Preparing for efficacy trials of vaginal microbicides in Indian women. Indian J Med Res. 2005 Apr;121(4):502-9.
- Background: PubMed 15743896Keller MJ, Tuyama A, Carlucci MJ, Herold BC. Topical microbicides for the prevention of genital herpes infection. J Antimicrob Chemother. 2005 Apr;55(4):420-3. doi: 10.1093/jac/dki056. Epub 2005 Mar 2.
- Background: PubMed 15923284Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect. 2005 Jun;81(3):193-200. doi: 10.1136/sti.2003.007153.
- Background: PubMed 15916473Weber J, Desai K, Darbyshire J; Microbicides Development Programme. The development of vaginal microbicides for the prevention of HIV transmission. PLoS Med. 2005 May;2(5):e142. doi: 10.1371/journal.pmed.0020142. Epub 2005 May 31.
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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.
Sharon L. Hillier, PhD principal investigator
University of Pittsburgh
Harold C. Wiesenfeld, MD principal investigator
University of Pittsburgh
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 National Institute of Allergy and Infectious Diseases (NIAID) 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 11 inclusion and 21 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 5 Mar 2009. 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?
Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441909, which also lists 5 linked publications.
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 5 Mar 2009.