HIV InfectionsPhase 1NCT00002327
The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
A Phase 1 study testing Cidofovir in people with HIV Infections and Condyloma Acuminata, run by Gilead Sciences at 11 sites in United States.
Trial summary
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can induce regression of condyloma acuminatum in patients with HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Condyloma Acuminata
- What is being tested?
- Cidofovir
- How many people
- 40 participants
- Where
- 11 sitesUnited States
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- AZT, ddI, ddC, d4T, or 3TC.
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
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- Fluconazole.
- Rifabutin.
- Clarithromycin.
- Patients must have:
- HIV seropositivity.
- Mean CD4 count >= 100 cells/mm3.
- External anogenital condyloma acuminatum confirmed by biopsy, present for less than 1 year. NOTE:
- Warts on anal, urethral, or vaginal mucosa will not be studied.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active lesions of genital herpes, other skin wounds, or active inflammatory skin disorders in the same area as warts to be treated.
- Active medical problems sufficient to hinder study compliance.
- Concurrent Medication:
- Excluded:
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- Podofilox or any podophyllum resin preparation.
- Liquid nitrogen treatment.
- Interferon alpha.
- Trichloracetic acid.
- Other treatments, topical or systemic, surgical or ablative, known to have anti-papilloma activity.
- Other investigative drugs (except d4T or 3TC) unless approved by the sponsor.
- Patients with the following prior conditions are excluded:
- History of untreated syphilis or Bowenoid papulosis.
- Prior Medication:
- Excluded within 4 weeks prior to study entry:
- Treatment for anogenital warts.
- Immunomodulators (including interferons or systemic corticosteroids).
- Lymphocyte replacement therapy.
- Biologic response modifiers. Substance abuse.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
East Bay AIDS Ctr
Berkeley, California, 94705
City and County of Denver / Dept of Health & Hosps
Denver, Colorado, 802044507
Houston Clinical Research Network
Houston, Texas, 77006
Dr Brad Bowden
Houston, Texas, 77027
Dr Stephen Tyring
Nassau Bay, Texas, 77058
Univ of Rochester Med Ctr
Rochester, New York, 14642
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
Univ California San Francisco
San Francisco, California, 941430316
Univ of Washington / Viral Disease Clinic
Seattle, Washington, 98122
Pacific Med Ctr
Seattle, Washington, 98144
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453
About this study
Official title: A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Condyloma Acuminatum in Patients With HIV Infection
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can induce regression of condyloma acuminatum in patients with HIV infection.
Read the detailed description
Four groups of 10 patients each receive topical HPMPC at 0.3 percent concentration for 5 or 10 days total or 1.0 percent concentration for 5 or 10 days total, followed by 2 weeks of rest. When six patients at a given dose and schedule have completed treatment and follow-up without significant toxicity, subsequent patients are entered at the next higher dose level. Patients are evaluated twice weekly during treatment and once weekly during the rest period. HPMPC may be extended for up to two additional courses in patients who experience no significant toxicity.
- Conditions
- HIV Infections, Condyloma Acuminata
- Being tested
- Cidofovir
- Keywords
- AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Condylomata Acuminata, cidofovir
- Medical subject headings
- HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CidofovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002327
- Sponsor's protocol ID
- 219A
- Other IDs
- GS-93-302
- Status last verified
- Aug 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Douglas J, Corey L, Tyring S, Kriesel J, Bowden B, Crosby D, Berger T, Conant M, McGuire B, Jaffe HS. A phase I/II study of cidofovir topical gel for refractory condyloma acuminatum in patients with HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:126 (abstract no 334)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Condyloma Acuminatum in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT00002327
- Acronym / sponsor ID
- 219A
- Conditions
- HIV Infections, Condyloma Acuminata
- Keywords
- AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Condylomata Acuminata, cidofovir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can induce regression of condyloma acuminatum in patients with HIV infection.
Detailed description
Four groups of 10 patients each receive topical HPMPC at 0.3 percent concentration for 5 or 10 days total or 1.0 percent concentration for 5 or 10 days total, followed by 2 weeks of rest. When six patients at a given dose and schedule have completed treatment and follow-up without significant toxicity, subsequent patients are entered at the next higher dose level. Patients are evaluated twice weekly during treatment and once weekly during the rest period. HPMPC may be extended for up to two additional courses in patients who experience no significant toxicity.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- AZT, ddI, ddC, d4T, or 3TC.
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
- Fluconazole.
Key exclusion criteria (20 listed)
- Active lesions of genital herpes, other skin wounds, or active inflammatory skin disorders in the same area as warts to be treated.
- Active medical problems sufficient to hinder study compliance.
- Podofilox or any podophyllum resin preparation.
- Liquid nitrogen treatment.
- Interferon alpha.
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 |
|---|---|---|
| Cidofovir | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
- BackgroundDouglas J, Corey L, Tyring S, Kriesel J, Bowden B, Crosby D, Berger T, Conant M, McGuire B, Jaffe HS. A phase I/II study of cidofovir topical gel for refractory condyloma acuminatum in patients with HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:126 (abstract no 334)
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 Cidofovir in people with HIV Infections and Condyloma Acuminata, run by Gilead Sciences at 11 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 14 inclusion and 20 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002327, which also lists 1 linked publication.
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 24 Jun 2005.