HIV Infections Clinical Trial
Official title:
An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex
AMENDED: 8/29/90 Inclusion of asymptomatic patients with CD4 counts less than 200 cells/mm3.
Standardization of baseline evaluation schedule to allow 14 days prior to study dosing.
Reduction in frequency and intensity of follow-up evaluations. Standardization of study
endpoints. Inclusion of toxicity scoring and management for amylase and triglyceride
elevations. Clarification of concomitant medication use. Original design: To determine the
effectiveness of didanosine (ddI) in patients with AIDS or advanced AIDS related complex
(ARC) who have documented hematologic intolerance to zidovudine (AZT) therapy. To determine
if the efficacy of ddI increases with increasing doses.
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the
first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.
However, AZT therapy has been associated with significant toxicities. In addition, the
effectiveness of AZT appears to decrease during the second and third years of therapy. For
these reasons, the development of alternative therapy that would be at least as effective
but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits
replication (reproduction) of HIV with less apparent toxicity than AZT. The major
dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs
of 2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8
to 51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These
neuropathy-like symptoms have generally not been associated with significant abnormalities
in nerve conduction studies and patients have reported marked improvement in symptoms within
1 to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced
dose after resolution of their symptoms. Studies indicate that ddI remains active in the
body for at least 12 hours. This indicates that benefits of ddI might be achieved with a low
frequency of drug administration.
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the
first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC.
However, AZT therapy has been associated with significant toxicities. In addition, the
effectiveness of AZT appears to decrease during the second and third years of therapy. For
these reasons, the development of alternative therapy that would be at least as effective
but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits
replication (reproduction) of HIV with less apparent toxicity than AZT. The major
dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs
of 2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8
to 51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These
neuropathy-like symptoms have generally not been associated with significant abnormalities
in nerve conduction studies and patients have reported marked improvement in symptoms within
1 to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced
dose after resolution of their symptoms. Studies indicate that ddI remains active in the
body for at least 12 hours. This indicates that benefits of ddI might be achieved with a low
frequency of drug administration.
Patients are randomized to one of three ddI treatment groups; within each group, doses will
be adjusted according to patient's weight at study entry. Stratification is by diagnosis of
AIDS or AIDS related complex (ARC) and Medical Center. Data will be tabulated for the Data
and Safety Monitoring Board at 3 month intervals.
;
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