Safety and Anti-HIV Activity of Capravirine Alone and in Combination With Other Anti-HIV Drugs
Status:
Completed
Trial end date:
2002-05-01
Target enrollment:
Participant gender:
Summary
This 2-part study will test the safety and anti-HIV activity of capravirine alone, and the
safety, anti-HIV activity, and drug interactions of capravirine combined with other anti-HIV
drugs. Capravirine belongs to a class of drugs called non-nucleoside reverse transcriptase
inhibitors (NNRTIs), which are effective when used together with other drugs, including
nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors.
Normal volunteers 18 years of age and older may enroll in Part 1 of the study. HIV-infected
patients 18 years of age and older who have not previously been treated with a NNRTI
(efavirenz, nevirapine, and delavirdine) may participate in Part 2. All prospective study
participants will be screened for eligibility with a physical examination, blood tests, a
urine test and an electrocardiogram (ECG).
Part 1 - Volunteers will be randomly assigned to one of two treatment groups as follows:
Group 1 will receive capravirine alone for 7 days and capravirine plus efavirenz (another
NNRTI) for an additional 10 days. On day 1, participants will have a physical examination,
urine test and laboratory blood tests. Blood samples will be collected just before the first
dose of capravirine is given and again at 0.5, 1, 2, 4, 6, 8 and 12 hours after the dose. A
small plastic tube will be placed in a vein to avoid multiple needle sticks. On day 8,
participants will have another physical examination and laboratory blood tests. Blood samples
will be drawn again as described above. In the evening of day 8, efavirenz will be added to
the regimen. On day 18 (the last day of the study), participants will have another physical
examination and blood tests. Blood will again be collected as described above.
Group 2 will take capravirine alone for 8) days and capravirine plus ritonavir (a protease
inhibitor) for an additional 8 days. Physical examinations, urine tests, and blood
collections will be done as described above on day 1, day 8 and day 16 (the last day) of the
study.
Part 2 - Patients will take capravirine alone for 7 days. On day 1, patients will have a
physical examination, urine test and laboratory blood tests. Blood samples will be collected
just before the first dose of capravirine is given and again at 0.5, 1, 2, 4, 6, 8 and 12
hours after the dose. A small plastic tube will be placed in a vein to avoid multiple needle
sticks. On day 8, patients will have another physical examination and laboratory blood tests.
Blood samples will be drawn again as described above. Additional drugs will then be added to
the regimen (in varying doses according to group), as follows:
Group 1 - efavirenz plus abacavir
Group 2 - ritonavir plus efavirenz plus abacavir
Group 3 - ritonavir plus efavirenz plus abacavir
On day 15, the procedures performed on day 8 will be repeated.
Patients will have the option of having blood drawn daily on days 2 through 7 to measure
HIV-1 viral load and of having a lumbar puncture (spinal tap) done between days 2 and 7 to
measure how well capravirine gets into the central nervous system.
After day 15, patients in all groups will continue with their drug regimen until week 48 or
until it is determined that the treatment is not effective for the patient. Physical
examinations, viral load measurements, white blood cell counts and other blood tests will be
done periodically throughout the trial. Within 4 weeks after the end of the study, patients
will be followed with another physical examination, blood and urine tests, and an ECG.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)