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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002290
• Other study ID #: 018A
• Secondary ID: 03
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• Zidovudine

• Acyclovir

Locations

Country	Name	City	State
United States	Veterans Administration Med Ctr	Bay Pines	Florida
United States	Birmingham Veterans Administration Med Ctr / Univ of Alabama	Birmingham	Alabama
United States	Univ of Virginia Health Sciences Ctr	Charlottesville	Virginia
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Harper Hosp	Detroit	Michigan
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Vanderbilt School of Medicine	Nashville	Tennessee
United States	Univ of Pennsylvania / HIV Clinic	Philadelphia	Pennsylvania
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	ViRx Inc	San Francisco	California
United States	Univ of Arizona / Health Science Ctr	Tucson	Arizona
United States	Georgetown Univ Med Ctr / Main Hosp 4	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,