The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC

HIV Infections Clinical Trial

Official title:

A Multicenter Uncontrolled Trial To Evaluate the Long Term Safety and Tolerance of Zidovudine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS and Advanced ARC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000999
• Other study ID #: ACTG 020
• Secondary ID: 10996
• Status: Completed
• Phase: Phase 1
• Est. completion date: March 1989

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity. 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.

Description:

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 1989
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Concurrent Medication:

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. Exclusion Criteria

Co-existing Condition:

• Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded.

Concurrent Medication: Excluded:

• Acetaminophen.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
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	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York
United States	Jack Weiler Hosp / Bronx Municipal Hosp	Bronx	New York
United States	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	LaJolla Veterans Administration Med Ctr	La Jolla	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Minnesota	Minneapolis	Minnesota
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	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Beth Israel Med Ctr / Peter Krueger Clinic	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 Pittsburgh Med School	Pittsburgh	Pennsylvania
United States	Univ of Rochester Medical Center	Rochester	New York
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	SUNY / State Univ of New York	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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)

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. — View Citation

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. — View Citation