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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002290 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
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

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.

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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine
  • Drug: Acyclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002290
018A, 03
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
February 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP