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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002063
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1990
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

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

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.
  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: NCT00002063

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002063     History of Changes
Other Study ID Numbers: 016A, VA Study 298
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:
Immune Tolerance
AIDS-Related Complex
Zidovudine

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

ClinicalTrials.gov processed this record on October 21, 2014