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| Descriptive Information Fields | |
| Brief Title † | 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. |
| 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. |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment, Open Label |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Herpes Simplex HIV Infections |
| Intervention † | Drug: Cidofovir |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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). |
| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002181 |
| Organization ID | 218B |
| Secondary IDs †† | GS-96-307 |
| Study Sponsor † | Gilead Sciences |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | November 1997 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |