Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Early Symptomatic HIV Infection
Zidovudine
+ Acyclovir
Blood-Borne Infections+15
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
This study focuses on treating early symptomatic HIV infection. It aims to understand the long-term safety and effectiveness of using two medications, Retrovir (Zidovudine) and Zovirax (Acyclovir), together compared to using Retrovir alone. The research is important because it could help improve treatment strategies for HIV, potentially reducing the severity and onset of related infections and symptoms, while also considering the impact on the immune system and viral replication.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, United StatesOpen Birmingham Veterans Administration Med Ctr / Univ of Alabama in Google MapsUniv of Arizona / Health Science Ctr
Tucson, United StatesViRx Inc
San Francisco, United StatesGeorgetown Univ Med Ctr / Main Hosp 4
Washington D.C., United States