The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acyclovir, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Patients must have: Early AIDS related complex (ARC). Willingness to be followed by the original study center for the duration of the trial (96 weeks). Ability to give informed consent. Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Fever > 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry. Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss). Concurrent Medication: Excluded: Acyclovir (ACV) therapy for chronic or recurrent herpes simplex. Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded. Prior Medication: Excluded within 4 weeks of study entry: Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity. Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2. Excluded within 8 weeks of study entry: Antiretroviral agents.
Sites / Locations
- Birmingham Veterans Administration Med Ctr / Univ of Alabama
- Univ of Arizona / Health Science Ctr
- ViRx Inc
- Georgetown Univ Med Ctr / Main Hosp 4
- Veterans Administration Med Ctr
- Rush Presbyterian - Saint Luke's Med Ctr
- Harper Hosp
- Univ of Pennsylvania / HIV Clinic
- Vanderbilt School of Medicine
- Univ TX Galveston Med Branch
- Baylor College of Medicine
- Univ of Utah School of Medicine
- Univ of Virginia Health Sciences Ctr
- Richmond AIDS Consortium