The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC
NCT ID: NCT00000999
Last Updated: 2021-11-04
Study Results
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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COMPLETED
PHASE1
500 participants
INTERVENTIONAL
1989-03-31
Brief Summary
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Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
Detailed Description
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This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (\> 72 hours) administration is not advised without dose supervision.
Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories:
* AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol.
* Patients who qualify for AZT under the labeling:
* (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and \< 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or \> 15 lbs or \> 10 percent of total body weight within the previous 3 months) and \< 200 T4 cells and one or more of the following symptoms:
* (1) fever \> 100 degrees F without infectious cause of \> 3 weeks duration; (2) clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites, cryptosporidia, and Mycobacterium avium-intracellulare.
Note:
* Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4 lymphocyte count, does not constitute an indication for AZT treatment under the labeling.
Concurrent Medication: Excluded:
* Acetaminophen.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Pettinelli C
Role: STUDY_CHAIR
Feinberg J
Role: STUDY_CHAIR
Locations
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LaJolla Veterans Administration Med Ctr
La Jolla, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
Stanford Univ School of Medicine
Stanford, California, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
SUNY / State Univ of New York
Syracuse, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Countries
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References
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Jacobson MA, Bacchetti P, Kolokathis A, Chaisson RE, Szabo S, Polsky B, Valainis GT, Mildvan D, Abrams D, Wilber J, et al. Surrogate markers for survival in patients with AIDS and AIDS related complex treated with zidovudine. BMJ. 1991 Jan 12;302(6768):73-8. doi: 10.1136/bmj.302.6768.73.
Jacobson MA, Abrams DI, Volberding PA, Bacchetti P, Wilber J, Chaisson RE, Crowe S, Howard W, Moss A. Serum beta 2-microglobulin decreases in patients with AIDS or ARC treated with azidothymidine. J Infect Dis. 1989 Jun;159(6):1029-36. doi: 10.1093/infdis/159.6.1029.
Jacobson MA, Abrams D, Bacchetti P, Kocurek K, Wilber J, Moss AR. Change in beta-2 microglobulin (B2M) during zidovudine (ZDV) therapy (RX) predicts clinical outcome. Int Conf AIDS. 1989 Jun 4-9;5:339 (abstract no TBP312)
Other Identifiers
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10996
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 020
Identifier Type: -
Identifier Source: org_study_id