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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002116
Other study ID # 218A
Secondary ID GS-93-301
Status Completed
Phase Phase 1
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date December 1995
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cidofovir


Locations

Country Name City State
Canada Univ of British Columbia / Univ Hosp Vancouver British Columbia
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of North Carolina Hosps Chapel Hill North Carolina
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Park Plaza Hosp Houston Texas
United States Los Angeles County - USC Med Ctr Los Angeles California
United States Mount Zion Med Ctr / UCSF San Francisco California
United States UCSF - San Francisco Gen Hosp San Francisco California
United States Univ of Washington / Viral Disease Clinic Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Acyclovir-resistant herpes: expanded access available for cidofovir gel (Forvade). AIDS Treat News. 1997 Feb 7;(No 264):5. — View Citation

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