Clinical trial NCT00002181: Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
Official title: Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Herpes Simplex
Acyclovir
Antiviral Agents
Gels
cidofovir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.

Detailed description: Patients receive open-label treatment with cidofovir gel.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS diagnosis per CDC criteria.
* At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
* Current HSV outbreak that is unresponsive to \>= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).

Concurrent Medication:

Excluded:

Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.

Required:

\>= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Mem Med Group Inc
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation Labs
state: California
city: Oceanside
country: United States
facility: Sharp Mission Park / Med Group
state: California
city: San Diego
country: United States
facility: Park Ctr for Health / Keith Vrhel
state: California
city: San Francisco
country: United States
facility: Potrero Hill Med Ctr
state: California
city: Santa Rosa
country: United States
facility: HIV Primary Care & Consult
state: California
city: Maitland
country: United States
facility: Central Florida Research Initiative
state: Florida
city: Atlanta
country: United States
facility: Braude Mermin Spivey MD PC
state: Georgia
city: Urbana
country: United States
facility: Christie Clinic / Urbana Campus
state: Illinois
city: Gardner
country: United States
facility: Heywood Memorial Hosp
state: Massachusetts
city: New York
country: United States
facility: Gouverneur Hosp
state: New York
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Dr Nicholaos Bellos
state: Texas
city: Dallas
country: United States
facility: Dr Susan M Diamond
state: Texas
city: Dallas
country: United States
facility: ID Associates
state: Texas
Study officials:
References: