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

NCT00000999 | Completed Phase 1

• 2 other identifiers: ACTG 02010996
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Co-existing Condition:
• Concurrent Medication: Excluded:
• Acetaminophen.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (23)

LaJolla Veterans Administration Med Ctr

La Jolla, California, 92037, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, 94115, United States

Location

Stanford Univ School of Medicine

Stanford, California, 94305, United States

Location

Louisiana State Univ Med Ctr / Tulane Med School

New Orleans, Louisiana, 70112, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess - West Campus

Boston, Massachusetts, 02215, United States

Location

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, 02215, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, 14215, United States

Location

Beth Israel Med Ctr / Peter Krueger Clinic

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY / State Univ of New York

Syracuse, New York, 13210, United States

Location

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, 10461, United States

Location

Jack Weiler Hosp / Bronx Municipal Hosp

The Bronx, New York, 10465, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States

Location

Related Publications (3)

• 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.

  PMID: 1671651 BACKGROUND

• 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.

  PMID: 2566637 BACKGROUND

• 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)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Pettinelli C

  STUDY CHAIR

• Feinberg J

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 1989
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (23)