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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


Phase 1
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Pettinelli C

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 020

NCT ID:

NCT00000999

Start Date:

Completion Date:

March 1989

Related Keywords:

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Zidovudine
  • Acquired Immunodeficiency Syndrome
  • HIV Infections

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
Los Angeles County - USC Med CtrLos Angeles, California  90033
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, California  94115
Stanford Univ School of MedicineStanford, California  94305
Louisiana State Univ Med Ctr / Tulane Med SchoolNew Orleans, Louisiana  70112
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Beth Israel Deaconess Med CtrBoston, Massachusetts  02215
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Univ of MinnesotaMinneapolis, Minnesota  55455
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, New York  10461
Jack Weiler Hosp / Bronx Municipal HospBronx, New York  10465
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Mount Sinai Med CtrNew York, New York  10029
Beth Israel Med Ctr / Peter Krueger ClinicNew York, New York  10003
SUNY / State Univ of New YorkSyracuse, New York  13210
Duke Univ Med CtrDurham, North Carolina  27710
Univ of Pittsburgh Med SchoolPittsburgh, Pennsylvania  
Johns Hopkins HospBaltimore, Maryland  21287
LaJolla Veterans Administration Med CtrLaJolla, California  92037