Know Cancer

forgot password

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
Not Enrolling
HIV Infections

Thank you

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:


- 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.


- 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

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:


Study Design:

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

Principal Investigator

Pettinelli C

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 020



Start Date:

Completion Date:

March 1989

Related Keywords:

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



Bellevue Hosp / New York Univ Med Ctr New York, New York  10016
Mem Sloan - Kettering Cancer Ctr New York, New York  10021
Univ of Rochester Medical Center Rochester, New York  14642
Los Angeles County - USC Med Ctr Los Angeles, California  90033
Univ of California / San Diego Treatment Ctr San Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med Ctr San Francisco, California  94115
Stanford Univ School of Medicine Stanford, California  94305
Louisiana State Univ Med Ctr / Tulane Med School New Orleans, Louisiana  70112
Tulane Univ School of Medicine New Orleans, Louisiana  70112
Beth Israel Deaconess Med Ctr Boston, Massachusetts  02215
Beth Israel Deaconess - West Campus Boston, Massachusetts  02215
Univ of Minnesota Minneapolis, Minnesota  55455
Bronx Municipal Hosp Ctr/Jacobi Med Ctr Bronx, New York  10461
Jack Weiler Hosp / Bronx Municipal Hosp Bronx, New York  10465
SUNY / Erie County Med Ctr at Buffalo Buffalo, New York  14215
Mount Sinai Med Ctr New York, New York  10029
Beth Israel Med Ctr / Peter Krueger Clinic New York, New York  10003
SUNY / State Univ of New York Syracuse, New York  13210
Duke Univ Med Ctr Durham, North Carolina  27710
Univ of Pittsburgh Med School Pittsburgh, Pennsylvania  
Johns Hopkins Hosp Baltimore, Maryland  21287
LaJolla Veterans Administration Med Ctr LaJolla, California  92037