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Sponsored by: |
Glaxo Wellcome |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002290 |
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.
Condition | Intervention |
HIV Infections |
Drug: Zidovudine Drug: Acyclovir |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Acyclovir Acyclovir sodium |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
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.
Prior Medication:
Excluded within 4 weeks of study entry:
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 | |||||
ViRx Inc | |||||
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 | |||||
Harper Hosp | |||||
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 | |||||
Baylor College of Medicine | |||||
Houston, Texas, United States, 77030 | |||||
Univ TX Galveston Med Branch | |||||
Galveston, Texas, United States, 77550 | |||||
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 |
Glaxo Wellcome |
Study ID Numbers: | 018A, 03 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002290 |
Health Authority: | United States: Food and Drug Administration |
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