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

NCT ID: NCT00002063

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Zidovudine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaxo Wellcome

INDUSTRY

Sponsor Role lead

Locations

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Wadsworth Veterans Administration Med Ctr

Los Angeles, California, United States

Site Status

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States

Site Status

Walter Reed Army Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Veterans Administration Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Dr Gordon Dickinson

Miami, Florida, United States

Site Status

Dr Gigi Diamond / New York Veterans Administration

New York, New York, United States

Site Status

Veterans Affairs Med Ctr / Admin Only / Not For Patient Care

Durham, North Carolina, United States

Site Status

Houston Veterans Administration Med Ctr

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VA Study 298

Identifier Type: -

Identifier Source: secondary_id

016A

Identifier Type: -

Identifier Source: org_study_id