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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002181 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Herpes Simplex HIV Infections |
Drug: Cidofovir |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS. |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
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).
Contacts and Locations| United States, California | |
| AIDS Healthcare Foundation Labs | |
| Los Angeles, California, United States, 90027 | |
| Potrero Hill Med Ctr | |
| San Francisco, California, United States, 94107 | |
| Mem Med Group Inc | |
| Long Beach, California, United States, 90806 | |
| Park Ctr for Health / Keith Vrhel | |
| San Diego, California, United States, 92103 | |
| HIV Primary Care & Consult | |
| Santa Rosa, California, United States, 95404 | |
| Sharp Mission Park / Med Group | |
| Oceanside, California, United States, 92054 | |
| United States, Florida | |
| Central Florida Research Initiative | |
| Maitland, Florida, United States, 32751 | |
| United States, Georgia | |
| Braude Mermin Spivey MD PC | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Christie Clinic / Urbana Campus | |
| Urbana, Illinois, United States, 61801 | |
| United States, Massachusetts | |
| Heywood Memorial Hosp | |
| Gardner, Massachusetts, United States, 01440 | |
| United States, New York | |
| Gouverneur Hosp | |
| New York, New York, United States, 10002 | |
| United States, Texas | |
| ID Associates | |
| Dallas, Texas, United States, 75231 | |
| Dr Nicholaos Bellos | |
| Dallas, Texas, United States, 75225 | |
| Dr Susan M Diamond | |
| Dallas, Texas, United States, 75225 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
More Information
| Study ID Numbers: | 218B, GS-96-307 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002181 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Herpes Simplex Acyclovir |
Antiviral Agents Gels cidofovir |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Physiological Effects of Drugs Infection Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Herpes Simplex Cidofovir RNA Virus Infections Anti-HIV Agents Immune System Diseases |
Skin Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Herpesviridae Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Radiation-Sensitizing Agents HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |
