Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

June 23, 2005 updated by: Glaxo Wellcome
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • Wadsworth Veterans Administration Med Ctr
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
      • Washington, District of Columbia, United States, 203075001
        • Walter Reed Army Med Ctr
    • Florida
      • Miami, Florida, United States, 33136
        • Dr Gordon Dickinson
    • New York
      • New York, New York, United States, 10010
        • Dr Gigi Diamond / New York Veterans Administration
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Med Ctr / Admin Only / Not For Patient Care
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with unstable disease characterized by the following are excluded:

  • Hospitalization within the past 14 days.
  • Major opportunistic infection, current or past.
  • An active infection of onset during the past 30 days, as evidenced by symptoms, signs, or laboratory abnormalities such as:
  • Temperature = or > 100.5 degrees F.
  • Night sweats.
  • Weight loss = or > 10 percent of body weight.
  • Diarrhea (3 or more bowel movements/day).
  • Persistent cough, shortness of breath, or dyspnea on exercise.
  • Abnormal chest x-ray suggesting pneumonia or increased arterial-alveolar (A-a) gradient.
  • Altered mental status, seizures, or focal neurologic signs.
  • Abnormal computerized tomography (CT) scan or magnetic resonance imaging (MRI) suggestive of toxoplasmosis, peripheral mononuclear leukocytes, lymphoma, or other focal abnormality of the central nervous system (CNS).
  • Abnormal cerebrospinal fluid (CSF) suggestive of cryptococcal, mycobacterial, or other meningitis. (The decision to perform invasive tests, such as lumbar puncture, specialized microbiological tests such as bone marrow culture for Mycobacteria or Histoplasma capsulatum, or specialized radiological tests such as CT scan or MRI should be based on clinical assessment of the patient.)
  • Kaposi's sarcoma.
  • Lymphoma; malignancy requiring chemotherapy.
  • Dementia.
  • Requiring hemodialysis or renal insufficiency or failure.
  • Leukopenia.
  • Thrombocytopenia.

Patients with the following are excluded:

  • Unstable disease.
  • Kaposi's sarcoma.
  • Lymphoma; malignancy requiring chemotherapy.
  • Dementia.
  • Major opportunistic infection, current or past.
  • Anemia (hemoglobin less than 9.5 g/dl).

Prior Medication:

Excluded within 1 month of study entry:

  • Ribavirin or zidovudine (AZT) or other antivirals.
  • Immunomodulating agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 016a
  • VA Study 298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Zidovudine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe