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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002290
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1990
  Purpose

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-Blind
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00002290

Locations
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

No publications provided

ClinicalTrials.gov Identifier: NCT00002290     History of Changes
Other Study ID Numbers: 018A, 03
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Acyclovir
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Acyclovir
Zidovudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 28, 2014