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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00002327

Collaborator

(none)

Enrollment

Locations

3.6

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Condyloma Acuminata	Drug: Cidofovir	Phase 1

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

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay AIDS Ctr	Berkeley	California	United States	94705
2	Univ California San Francisco	San Francisco	California	United States	941430316
3	City and County of Denver / Dept of Health & Hosps	Denver	Colorado	United States	802044507
4	Bronx-Lebanon Hosp Ctr	Bronx	New York	United States	10453
5	Univ of Rochester Med Ctr	Rochester	New York	United States	14642
6	Houston Clinical Research Network	Houston	Texas	United States	77006
7	Dr Brad Bowden	Houston	Texas	United States	77027
8	Dr Stephen Tyring	Nassau Bay	Texas	United States	77058
9	Univ of Utah School of Medicine	Salt Lake City	Utah	United States	84132
10	Univ of Washington / Viral Disease Clinic	Seattle	Washington	United States	98122
11	Pacific Med Ctr	Seattle	Washington	United States	98144