Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002045
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002045 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002045
014E, 15
Not Provided
Not Provided
Glaxo Wellcome
Not Provided
Not Provided
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