The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Zidovudine (Drug); Acyclovir (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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
Study design: Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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, 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
Additional Information
Last updated: June 23, 2005
|