A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To compare the effect of zidovudine (AZT) given alone with the combination of AZT and acyclovir (ACV) on the human immunodeficiency virus (HIV) in persons infected with HIV, and to study the pharmacokinetics (how fast AZT reaches certain levels in blood and how long it remains), safety, and effectiveness of AZT given alone and in combination with ACV in treating HIV-infected patients. Other studies have shown that AZT offers potential benefits to specific AIDS patients when given over long time periods, and experiments in vitro (in the test tube) suggest that ACV may stimulate the action of AZT against HIV. It is necessary to obtain information on how these drugs perform in HIV-infected humans.

Key facts

Study ID

NCT00001010

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

72

Expected to finish

1990-10-01

Last updated by the study team

2021-11-04

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Active drug or alcohol abuse.
• Concurrent Medication:
• Excluded:
• Any chronic systemic medications.
• Aspirin.
• Cimetidine.
• Flurazepam.
• Indomethacin.
• Ranitidine.
• Probenecid.
• Excluded during first 2 weeks of study:
• Any chronic ( > 3 days) medication.
• Acetaminophen and other drugs that are metabolized by hepatic glucuronidation.
• Prior Medication:
• Excluded:
• Zidovudine (AZT) at any time.
• Excluded within 14 days of study entry:
• Other experimental therapy.
• Drugs which cause neutropenia or significant nephrotoxicity.
• Rifampin or rifampin derivatives.
• Systemic anti-infectives.
• Excluded within 30 days of study entry:
• Immunomodulating agents.
• Excluded within 3 months of study entry:
• Any antiretroviral agent.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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