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.
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Mem Med Group Inc, Long Beach, California 90806, United States
AIDS Healthcare Foundation Labs, Los Angeles, California 90027, United States
Sharp Mission Park / Med Group, Oceanside, California 92054, United States
Park Ctr for Health / Keith Vrhel, San Diego, California 92103, United States
Potrero Hill Med Ctr, San Francisco, California 94107, United States
HIV Primary Care & Consult, Santa Rosa, California 95404, United States
Central Florida Research Initiative, Maitland, Florida 32751, United States
Braude Mermin Spivey MD PC, Atlanta, Georgia 30309, United States
Christie Clinic / Urbana Campus, Urbana, Illinois 61801, United States
Heywood Memorial Hosp, Gardner, Massachusetts 01440, United States
Gouverneur Hosp, New York, New York 10002, United States
Central Texas Med Foundation, Austin, Texas 78751, United States
Dr Nicholaos Bellos, Dallas, Texas 75225, United States
Dr Susan M Diamond, Dallas, Texas 75225, United States
ID Associates, Dallas, Texas 75231, United States