Clinical Trials


The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

This study has been completed
Glaxo Wellcome

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

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.

Condition Intervention
HIV Infections

Drug : Zidovudine
Drug : Acyclovir

Study Type: Interventional
Study Design: Masking: Double
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  


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:
  • 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.

contacts and locations

Contacts and Locations

Choosing 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 identifier: NCT00002290


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
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 Collaborators

Glaxo Wellcome
More Information

More Information

Responsible Party: Glaxo Wellcome 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
AIDS-Related Complex

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Acyclovir processed this data on April 08, 2020
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