Clinical trial NCT00002327: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Condyloma Acuminata
Keywords: AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Condylomata Acuminata
cidofovir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: San Francisco
country: United States
facility: Univ California San Francisco
state: California
city: Denver
country: United States
facility: City and County of Denver / Dept of Health & Hosps
state: Colorado
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Houston
country: United States
facility: Dr Brad Bowden
state: Texas
city: Nassau Bay
country: United States
facility: Dr Stephen Tyring
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah School of Medicine
state: Utah
city: Seattle
country: United States
facility: Univ of Washington / Viral Disease Clinic
state: Washington
city: Seattle
country: United States
facility: Pacific Med Ctr
state: Washington
Study officials:
References:
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)