Genital WartsPhase 1NCT00499967
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts
A Phase 1 study testing GS-9191 ointment and GS-9191 in people with Genital Warts, run by Gilead Sciences at 25 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Genital Warts
- What is being tested?
- GS-9191 ointment and GS-9191
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 25 sitesUnited States
- Study dates
- Aug 2007to Mar 2009
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Have 2 or more genital warts of prespecified sizes on external surfaces of the body.
- If HIV positive, have HIV RNA < 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen
Who cannot join
- Prior genital wart treatment within 8 weeks
- Pregnancy or breast-feeding
- Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis)
- Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months
- Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Beverly Hills, California, 90211
Study site
Chattanooga, Tennessee, 37404
Study site
Dallas, Texas, 75231
Study site
Greenville, South Carolina, 29605
Study site
Houston, Texas, 77058
Study site
Indianapolis, Indiana, 46202
Study site
Las Vegas, Nevada, 89106
Study site
Mission Viejo, California, 92691
Study site
New York, New York, 10016
Study site
Orlando, Florida, 32803
Study site
Portland, Oregon, 97239
Study site
Raleigh, North Carolina, 27612
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78217
Study site
San Antonio, Texas, 78229
Study site
San Francisco, California, 94114
Study site
San Francisco, California, 94115
Study site
Santa Rosa, California, 95405
Study site
Seattle, Washington, 98101
Study site
St Louis, Missouri, 63117
Study site
Stony Brook, New York, 11794
Study site
Tampa, Florida, 33607
Study site
Tucson, Arizona, 85710
Study site
Tulsa, Oklahoma, 74105
Study site
Vallejo, California, 94589
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Assessment of the Safety, Tolerability, and Activity of GS-9191 Ointment for the Treatment of External Genital and Perianal Warts Caused by Human Papilloma Virus Infection
The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.
- Conditions
- Genital Warts
- Being tested
- GS-9191 ointment, GS-9191, Placebo
- Keywords
- genital warts, venereal warts, human papilloma virus
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9191 ointmentDrug
GS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
GS-9191Drug
GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort.
PlaceboDrug
Placebo matching GS-9191 ointment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | GS-9191 0.01% ointment Receives: Drug: GS-9191 ointment |
| Cohort 2 | Experimental | GS-9191 0.03% ointment Receives: Drug: GS-9191 ointment |
| Cohort 3 | Experimental | GS-9191 0.1% ointment Receives: Drug: GS-9191 ointment |
| Cohort 4 | Active comparator | GS-9191 0.3% Receives: Drug: GS-9191 |
| Cohort 5 | Active comparator | GS-9191 1.0% Receives: Drug: GS-9191 |
| Cohorts 1, 2, 3, 4 & 5 | Placebo comparator | Placebo in all cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital WartsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elsa Mondou, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499967
- Sponsor's protocol ID
- GS-US-197-0101
- Status last verified
- Apr 2009
- First submitted
- 10 Jul 2007
- Last updated
- 9 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Assessment of the Safety, Tolerability, and Activity of GS-9191 Ointment for the Treatment of External Genital and Perianal Warts Caused by Human Papilloma Virus Infection
- ClinicalTrials.gov ID
- NCT00499967
- Acronym / sponsor ID
- GS-US-197-0101
- Conditions
- Genital Warts
- Keywords
- genital warts, venereal warts, human papilloma virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Jul 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.
The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GS-9191 ointmentGS-9191 0.01% ointment |
| Cohort 2 | Experimental | Drug: GS-9191 ointmentGS-9191 0.03% ointment |
| Cohort 3 | Experimental | Drug: GS-9191 ointmentGS-9191 0.1% ointment |
| Cohort 4 | Active comparator | Drug: GS-9191GS-9191 0.3% |
| Cohort 5 | Active comparator | Drug: GS-9191GS-9191 1.0% |
| Cohorts 1, 2, 3, 4 & 5 | Placebo comparator | Drug: PlaceboPlacebo in all cohorts |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have 2 or more genital warts of prespecified sizes on external surfaces of the body.
- If HIV positive, have HIV RNA < 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen
Key exclusion criteria (5 listed)
- Prior genital wart treatment within 8 weeks
- Pregnancy or breast-feeding
- Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis)
- Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months
- Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area
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 |
|---|---|---|
| GS-9191 ointmentGS-9191 ointment (0.01%, 0.03%, or 0.1%) or placebo applied topically to anogenital warts for one or three cycles, each cycle lasting 5 consecutive nights of ointment application followed by 9 nights off-ointment. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| GS-9191GS-9191 ointment (0.3% or 1.0%) or placebo applied topically to anogenital warts for one or three cycles; each cycle consists of dosing occuring over a 5-night period with ointment application on nights 1, 3 and 5 followed by a 9-day off-ointment period. The strength of GS-9191 ointment is cohort-dependent, with escalation to higher dose cohorts dependent upon safety and tolerability in the previous cohort. | Drug | Cohort 4, Cohort 5 |
| PlaceboPlacebo matching GS-9191 ointment | Drug | Cohorts 1, 2, 3, 4 & 5 |
Primary outcome
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment.
Time frame: 3 months
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 9 Apr 2009.
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Warts
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.
Elsa Mondou, MD study director
Gilead Sciences
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-9191 ointment and GS-9191 in people with Genital Warts, run by Gilead Sciences at 25 sites 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 2 inclusion and 5 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 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
Regression of anogenital warts based on the total surface area involved by treated warts before, during, and after treatment. (time frame: 3 months). 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 Apr 2009.