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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Zidovudine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Pettinelli C, Study Chair
Feinberg J, Study Chair

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

LaJolla Veterans Administration Med Ctr, LaJolla, California 92037, United States

Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States

Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California 941102859, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

Stanford Univ School of Medicine, Stanford, California 94305, United States

Louisiana State Univ Med Ctr / Tulane Med School, New Orleans, Louisiana 70112, United States

Tulane Univ School of Medicine, New Orleans, Louisiana 70112, United States

Johns Hopkins Hosp, Baltimore, Maryland 21287, United States

Beth Israel Deaconess - West Campus, Boston, Massachusetts 02215, United States

Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States

Univ of Minnesota, Minneapolis, Minnesota 55455, United States

Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States

Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States

SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Beth Israel Med Ctr / Peter Krueger Clinic, New York, New York 10003, United States

Mem Sloan - Kettering Cancer Ctr, New York, New York 10021, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Univ of Rochester Medical Center, Rochester, New York 14642, United States

SUNY / State Univ of New York, Syracuse, New York 13210, United States

Duke Univ Med Ctr, Durham, North Carolina 27710, United States

Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania, United States

Additional Information

Click here for more information about Zidovudine

Related publications:

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.

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.

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)


Last updated: March 15, 2012

Page last updated: August 23, 2015

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