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 Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002116
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002116 on ClinicalTrials.gov Archive Site
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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 Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
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 Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Herpes Simplex
  • HIV Infections
Drug: Cidofovir
Not Provided
[No authors listed] Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy with AZT, ddI, ddC, or d4T.
  • Oral trimethoprim/sulfamethoxazole.
  • Dapsone.
  • Atovaquone.
  • Fluconazole.
  • Rifabutin.
  • Clarithromycin.

Patients must have:

  • HIV seropositivity.
  • Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
  • Measurable lesions.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active medical problems sufficient to hinder study compliance or assessment of treatment effect.

Concurrent Medication:

Excluded:

  • Acyclovir.
  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs (except d4T).
  • Amphotericin.
  • Intravenous therapy for PCP.
  • Chemotherapeutic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs with potential anti-HSV activity.
  • Amphotericin.
  • Intravenous therapy for PCP.

Excluded within 4 weeks prior to study entry:

  • Chemotherapeutic agents.

Required:

  • At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).

Substance abuse.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002116
218A, GS-93-301
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
December 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP