Herpes Simplex, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Herpes Simplex, Acyclovir, Antiviral Agents, Gels, cidofovir
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.
Interventions
DRUGCidofovir
Sponsors
Gilead Sciences
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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).
Countries
United States
Outcome results
None listed