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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


Phase 1
18 Years
N/A
Not Enrolling
Both
HIV Infections, Condyloma Acuminata

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

219A

NCT ID:

NCT00002327

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Condyloma Acuminata
  • AIDS-Related Opportunistic Infections
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • Condylomata Acuminata
  • cidofovir
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Condylomata Acuminata

Name

Location

Univ of Utah School of MedicineSalt Lake City, Utah  84132
Bronx-Lebanon Hosp CtrBronx, New York  10453
Houston Clinical Research NetworkHouston, Texas  77266
East Bay AIDS CtrBerkeley, California  94705
Univ California San FranciscoSan Francisco, California  941430316
City and County of Denver / Dept of Health & HospsDenver, Colorado  802044507
Univ of Rochester Med CtrRochester, New York  14642
Dr Brad BowdenHouston, Texas  77027
Dr Stephen TyringNassau Bay, Texas  77058
Univ of Washington / Viral Disease ClinicSeattle, Washington  98122
Pacific Med CtrSeattle, Washington  98144