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
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective Double-Blind Study of Retrovir in Early 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

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.

  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: NCT00002045

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002045     History of Changes
Other Study ID Numbers: 014E, 15
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:
Prospective Studies
Zidovudine

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

ClinicalTrials.gov processed this record on September 16, 2014