search
Back to results

The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients

Primary Purpose

HIV Infections, Condyloma Acuminata

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cidofovir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Condylomata Acuminata, cidofovir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: AZT, ddI, ddC, d4T, or 3TC. Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. 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. Exclusion Criteria 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: 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.

Sites / Locations

  • East Bay AIDS Ctr
  • Univ California San Francisco
  • City and County of Denver / Dept of Health & Hosps
  • Bronx-Lebanon Hosp Ctr
  • Univ of Rochester Med Ctr
  • Houston Clinical Research Network
  • Dr Brad Bowden
  • Dr Stephen Tyring
  • Univ of Utah School of Medicine
  • Univ of Washington / Viral Disease Clinic
  • Pacific Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00002327
Brief Title
The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Condyloma Acuminata
Keywords
AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Condylomata Acuminata, cidofovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cidofovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: AZT, ddI, ddC, d4T, or 3TC. Oral trimethoprim/sulfamethoxazole. Aerosolized pentamidine. Dapsone. 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. Exclusion Criteria 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: 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.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Univ California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
941430316
Country
United States
Facility Name
City and County of Denver / Dept of Health & Hosps
City
Denver
State/Province
Colorado
ZIP/Postal Code
802044507
Country
United States
Facility Name
Bronx-Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10453
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Dr Brad Bowden
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Dr Stephen Tyring
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Univ of Washington / Viral Disease Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Pacific Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background

Learn more about this trial

The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients

We'll reach out to this number within 24 hrs