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A Prospective Double-Blind Study of Retrovir in Early HIV Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002045
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Prospective Double-Blind Study of Retrovir in Early HIV Infection
A Prospective Double-Blind Study of Retrovir in Early HIV Infection

To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.

(12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.

Not Provided
Interventional
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Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
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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

Concurrent Treatment:

Allowed:

  • Electron beam therapy to an area of less than 100 cm2.

Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).

  • Patient must be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
  • Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
  • Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
  • extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
  • Evidence of compromised bone marrow function defined by specified lab values.
  • Evidence of HIV neurologic disease.
  • Evidence of HIV-associated "wasting syndrome".
  • Hypersensitivity to zidovudine (AZT).

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapeutic agents.
  • Steroids.
  • Interferon or immunomodulating agents.
  • Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.

Patients with the following are excluded:

  • Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
  • extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
  • Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
  • Evidence of HIV-associated wasting syndrome.
  • Hypersensitivity to retrovir.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Interferon.
  • Immunomodulating agents.
  • Myelosuppressive drugs.
  • Nephrotoxic agents.
  • Other experimental chemotherapy.

Prior Treatment:

Excluded:

  • Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).

Chronic alcohol or drug abuse.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002045
014E
15
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
December 1989

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