Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
2 other identifiers
interventional
N/A
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
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8 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.
You may not qualify if:
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (8)
Wadsworth Veterans Administration Med Ctr
Los Angeles, California, 90073, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Walter Reed Army Med Ctr
Washington D.C., District of Columbia, 203075001, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, United States
Dr Gordon Dickinson
Miami, Florida, 33136, United States
Dr Gigi Diamond / New York Veterans Administration
New York, New York, 10010, United States
Veterans Affairs Med Ctr / Admin Only / Not For Patient Care
Durham, North Carolina, 27705, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-01