A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

NCT00000700 | Completed Phase 3

• 2 other identifiers: ACTG 00210978
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 28

Brief Summary

To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.

Conditions

HIV Infections

Keywords

United States; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• All concomitant medication to minimum and record.
• Any approved medications can be used to treat an opportunistic infection.
• Dapsone may be used for Pneumocystis carinii pneumonia (PCP).
• Pyrimethamine - sulfadoxine may be used for toxoplasmosis.
• Ganciclovir for cytomegalovirus may be used for maintenance only.
• Prophylactic therapy for PCP.
• Concurrent Treatment:
• Allowed:
• Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is \< 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or \< 3000 rads total is used.
• Patients must have:
• HIV seropositivity as confirmed by any federally licensed ELISA test kit.
• Allowed:
• Malignancy in past which has been in complete remission for 1 year without therapy.

You may not qualify if:

• Co-existing Condition:
• Patients with active opportunistic infections will be excluded.
• Concurrent Medication:
• Excluded:
• Aspirin on a regular basis or beyond 72 hours without contacting investigator.
• Cimetidine.
• Flurazepam.
• Indomethacin.
• Ranitidine.
• Probenecid.
• Patients with the following are excluded:
• Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry.
• Other concurrent neoplasms other than basal cell carcinoma of the skin.
• Requiring blood transfusions \> once per month. Last transfusion cannot have been given within 7 days of entry.
• Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary.

Sponsors & Collaborators

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

Study Sites (28)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, 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

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, 70112, 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

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, 02114, 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

City Hosp Ctr at Elmhurst / Mount Sinai Hosp

Elmhurst, New York, 11373, United States

Location

Beth Israel Med Ctr / Peter Krueger Clinic

New York, New York, 10003, 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

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

Bronx Veterans Administration / Mount Sinai Hosp

The Bronx, New York, 10468, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States

Location

Univ of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (9)

• Fischl M, Parker CB, Pettinelli C, Wulfsohn M, Rasheed S. The efficacy and safety of a lower dose of zidovudine in the treatment of patients with AIDS-associated PCP. Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no ThB20)

  BACKGROUND

• De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1993 Apr;6(4):359-65.

  PMID: 8095980 BACKGROUND

• McMahon DK, Winkelstein A, Armstrong JA, Pazin GJ, Hawk H, Ho M. Zidovudine therapy is associated with an increased capacity of phytohemagglutinin-stimulated cells to express interleukin-2 receptors. Pittsburgh AIDS Clinical Trial Unit. AIDS. 1991 May;5(5):491-6. doi: 10.1097/00002030-199105000-00003.

  PMID: 1863401 BACKGROUND

• Richman DD, Grimes JM, Lagakos SW. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. J Acquir Immune Defic Syndr (1988). 1990;3(8):743-6.

  PMID: 2114476 BACKGROUND

• Wulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419)

  BACKGROUND

• Rinaldo C, Huang XL, Piazza P, Armstrong J, Rappocciolo G, Pazin G, McMahon D, Gupta P, Fan Z, Zhang Z, et al. Augmentation of cellular immune function during the early phase of zidovudine treatment of AIDS patients. J Infect Dis. 1991 Oct;164(4):638-45. doi: 10.1093/infdis/164.4.638.

  PMID: 1680135 BACKGROUND

• Fischl MA, Parker CB, Pettinelli C, Wulfsohn M, Hirsch MS, Collier AC, Antoniskis D, Ho M, Richman DD, Fuchs E, et al. A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1990 Oct 11;323(15):1009-14. doi: 10.1056/NEJM199010113231501.

  PMID: 1977079 BACKGROUND

• Unadkat JD, Collier AC, Crosby SS, Cummings D, Opheim KE, Corey L. Pharmacokinetics of oral zidovudine (azidothymidine) in patients with AIDS when administered with and without a high-fat meal. AIDS. 1990 Mar;4(3):229-32. doi: 10.1097/00002030-199003000-00008.

  PMID: 2350441 BACKGROUND

• Coombs RW, Collier AC, Allain JP, Nikora B, Leuther M, Gjerset GF, Corey L. Plasma viremia in human immunodeficiency virus infection. N Engl J Med. 1989 Dec 14;321(24):1626-31. doi: 10.1056/NEJM198912143212402.

  PMID: 2511447 BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis; Acquired Immunodeficiency Syndrome

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; Opportunistic Infections; Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract 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

• Fischl M

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 1990
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (28)