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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Immune Tolerance, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wadsworth Veterans Administration Med Ctr
  • San Francisco Veterans Administration Med Ctr
  • Walter Reed Army Med Ctr
  • Veterans Administration Med Ctr
  • Dr Gordon Dickinson
  • Dr Gigi Diamond / New York Veterans Administration
  • Veterans Affairs Med Ctr / Admin Only / Not For Patient Care
  • Houston Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002063
Brief Title
Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
Official Title
Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
Study Type
Interventional

2. Study Status

Record Verification Date
January 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Immune Tolerance, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Wadsworth Veterans Administration Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Walter Reed Army Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
203075001
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Dr Gordon Dickinson
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Dr Gigi Diamond / New York Veterans Administration
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Veterans Affairs Med Ctr / Admin Only / Not For Patient Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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