The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: February 1990
History of Changes
This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.
Drug : Zidovudine
Drug : Acyclovir
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Double-Blind Trial to Evaluate the Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Patients With Early Symptomatic Human Immunodeficiency Virus (HIV) Infection|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- 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).
- Acyclovir (ACV) therapy for chronic or recurrent herpes simplex.
- 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.
Patients with the following are excluded:
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.
Excluded within 4 weeks of study entry:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002290
Locations Show More
|United States, Alabama|
|Birmingham Veterans Administration Med Ctr / Univ of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Univ of Arizona / Health Science Ctr|
|Tucson, Arizona, United States, 85724|
|United States, California|
|San Francisco, California, United States, 94103|
|United States, District of Columbia|
|Georgetown Univ Med Ctr / Main Hosp 4|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|Veterans Administration Med Ctr|
|Bay Pines, Florida, United States, 33504|
|United States, Illinois|
|Rush Presbyterian - Saint Luke's Med Ctr|
|Chicago, Illinois, United States, 60612|
|United States, Michigan|
|Detroit, Michigan, United States, 48201|
|United States, Pennsylvania|
|Univ of Pennsylvania / HIV Clinic|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Vanderbilt School of Medicine|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Univ TX Galveston Med Branch|
|Galveston, Texas, United States, 77550|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Univ of Utah School of Medicine|
|Salt Lake City, Utah, United States, 84132|
|United States, Virginia|
|Univ of Virginia Health Sciences Ctr|
|Charlottesville, Virginia, United States, 22908|
|Richmond AIDS Consortium|
|Richmond, Virginia, United States, 23219|
Sponsors and CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov Identifier:||NCT00002290 History of Changes|
|Other Study ID Numbers:||018A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.