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To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.
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Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Treatment:
Allowed:
Patients with the following are excluded:
Any immediately life-threatening infection or medical condition present at the time of study entry.
Any active opportunistic or other infection requiring chronic therapy present at the time of study entry.
Patients with Pneumocystis carinii pneumonia (PCP) may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 degrees C for at least 48 hours; oxygen (on room air)
= or > 60 mm, and arterial / alveolar gradient = or < 30 mm.
Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
Seropositive for HIV antibody documented by any federally licensed ELISA.
Patients must have ability to give informed consent and advanced HIV disease defined as:
OR History of other opportunistic infection included in the CDC surveillance definition of AIDS (stage IV-C-1), diagnosed within 4 months of entry, but not requiring chronic suppressive therapy, and a CD4+ cell count < 200 cells/mm3.
OR AIDS related complex (ARC) only those patients with a CD4+ count < 200 cells/mm3 and documentation of at least two signs or symptoms from the list below. One sign or symptom must be weight loss or candidiasis as described.
Negative Venereal Disease Research Laboratory (VDRL) or Rapid Plasma Reagent (RPR) or, if positive and verified by Fluorescent Treponemal Antibody Absorption (FTAABS), documented history of treatment for syphilis. If FTAABS is positive, but treatment history is not available, the patient may be entered 3 or more days following the initiation of appropriate chemotherapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Active drug or alcohol abuse.
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Data sourced from clinicaltrials.gov
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