The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
Herpes Simplex, HIV Infections
About this trial
This is an interventional treatment trial for Herpes Simplex focused on measuring Herpes Simplex, Acyclovir, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Patients must have: Parts A and B: Documented HIV infection. Patients >= 18 years of age must be willing and able to give informed consent and patients < 18 years must have written consent from a parent or guardian. Part A: CD4+ T count < 250 cells/mm3 within 1 month prior to study entry. Documented antibodies to HSV any time prior to study. History of HSV outbreak in past 2 to 12 months. Former Part B patients who have completed the 12 week follow up may enter Part A after at least a 4-week washout. Part B: Documented CD4+ T count < 250 cells/mm3 anytime prior to study entry. Oral, genital or anorectal lesions with a vesiculopustular component. Presumptive diagnosis of HSV. Former part A patients may enter part B after a 4-week washout. Exclusion Criteria Patients with any of the following prior conditions are excluded: Documented or suspected HSV within 2 months prior to study entry. History of infection with an acyclovir resistant HSV strain. History of disseminated HSV. History of treatment for acute CMV or MAC disease. History of poor medication or clinic visit compliance. Prior Medication: Excluded: Use of acyclovir, famciclovir, foscarnet, ganciclovir, valacyclovir or cidofovir for any reason within one month prior to study entry. [AS PER AMENDMENT 1/21/97: Use of antiherpes agents, both FDA-approved and investigational, including bis-POM, PMEA, lobucavir, acyclovir, etc.] Initiation or modification of antiretroviral therapy, immunomodulators, or any kind of vaccination within 2 months prior to study entry. Treatment for acute medical condition within 4 weeks prior to study entry.
Sites / Locations
- AIDS Research Ctr
- Harbor-UCLA Med Ctr
- Yale Univ School of Medicine / AIDS Program
- North Broward Hosp District
- Univ of Miami / Jackson Memorial Hosp
- Univ of Illinois - Chicago
- Univ of Illinois Chicago / Howard Brown Hlth Ctr
- Johns Hopkins Univ
- SUNY Brooklyn / SUNY Health Sciences Ctr at Brooklyn
- Community Research Initiative on AIDS
- NYU - Bellevue Hosp
- New York Med College / Westchester County Med Ctr
- Research and Education Group
- Univ of Pennsylvania Med Ctr
- Brown Univ / The Miriam Hosp