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

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.