HIV Infections Clinical Trial
Official title:
The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS
To determine the safety and effectiveness of clindamycin and primaquine in the treatment of
mild Pneumocystis carinii pneumonia (PCP) in AIDS patients.
As many as 80 percent of AIDS patients experience at least one episode of PCP and about
one-third of these patients have a recurrence of the disease. Drugs currently used for
treatment of acute PCP are toxic to the majority of AIDS patients. The combination of
clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in
animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been
used safely in humans for treatment of other diseases. It is possible that the combination
may prove to be as good or better than standard therapy for PCP and side effects may be
less.
As many as 80 percent of AIDS patients experience at least one episode of PCP and about
one-third of these patients have a recurrence of the disease. Drugs currently used for
treatment of acute PCP are toxic to the majority of AIDS patients. The combination of
clindamycin and primaquine reduces the numbers of PCP organisms in laboratory tests and in
animal studies. Both drugs can be given orally, concentrate in lung tissue, and have been
used safely in humans for treatment of other diseases. It is possible that the combination
may prove to be as good or better than standard therapy for PCP and side effects may be
less.
The proposal for the first 20 patients enrolled in ACTG 044 initially called for an
open-labelled, pilot study of intravenous (IV) clindamycin and primaquine therapy in
patients with mild to moderate PCP. Preliminary results of the first 22 patients entered
into ACTG 044 indicate that the response rate to therapy was over 90 percent. The rate of
discontinuation secondary to toxic side effects was only 20 percent. Additional uncontrolled
studies have shown an excellent clinical response and safety profile in another 60 patients.
The protocol has been amended to provide an all oral dosing regimen. An additional 20
patients with mild PCP will be enrolled and tested with oral clindamycin and primaquine on
an outpatient basis. All patients will receive clindamycin and primaquine. Total duration of
therapy will be 21 days. Patients may be hospitalized at any time during the study as
clinically indicated. Treatment with zidovudine may be started or resumed after completion
of clindamycin / primaquine therapy.
AMENDED: An additional 30 patients instead of 20 patients with mild PCP will be enrolled.
;
Masking: Open Label, Primary Purpose: Treatment
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