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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: | Masking: Open Label Primary Purpose: Treatment |
| 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 | |
| Mem Med Group Inc | |
| Long Beach, California, United States, 90806 | |
| AIDS Healthcare Foundation Labs | |
| Los Angeles, California, United States, 90027 | |
| Sharp Mission Park / Med Group | |
| Oceanside, California, United States, 92054 | |
| Park Ctr for Health / Keith Vrhel | |
| San Diego, California, United States, 92103 | |
| Potrero Hill Med Ctr | |
| San Francisco, California, United States, 94107 | |
| HIV Primary Care & Consult | |
| Santa Rosa, California, United States, 95404 | |
| 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 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| Dr Nicholaos Bellos | |
| Dallas, Texas, United States, 75225 | |
| Dr Susan M Diamond | |
| Dallas, Texas, United States, 75225 | |
| ID Associates | |
| Dallas, Texas, United States, 75231 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002181 History of Changes |
| Other Study ID Numbers: | 218B, GS-96-307 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Herpes Simplex Acyclovir |
Antiviral Agents Gels cidofovir |
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections |
Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Acyclovir Cidofovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents |
