The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
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
2 other identifiers
interventional
N/A
1 country
14
Brief Summary
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.
Trial Health
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14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (14)
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, Alabama, 35233, United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
ViRx Inc
San Francisco, California, 94103, United States
Georgetown Univ Med Ctr / Main Hosp 4
Washington D.C., District of Columbia, 20007, United States
Veterans Administration Med Ctr
Bay Pines, Florida, 33504, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Harper Hosp
Detroit, Michigan, 48201, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt School of Medicine
Nashville, Tennessee, 37232, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908, United States
Richmond AIDS Consortium
Richmond, Virginia, 23219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-02