This study examined the interactions of various drugs used to treat HIV infection in order to
design larger studies of possible combinations for people who continue to have high viral
levels despite combination therapy.
HIV-infected patients 18 years of age and older who have a viral load of at least 500
copies/mL; who have received 20 weeks of protease inhibitor therapy, with the same protease
inhibitors in combination therapy for the last 12 weeks; and who have never been treated with
abacavir, amprenavir or efavirenz were enrolled.
All patients will receive 600 milligrams a day of efavirenz (a non-nucleoside reverse
transcriptase inhibitor); 300 mg twice daily of abacavir (a nucleoside analog); and 1200 mg
twice a day of amprenavir (a protease inhibitor). In addition to these drugs, six patients
will receive 500 mg twice a day of ritonavir (a protease inhibitor); six patients will
receive 200 mg twice a day of ritonavir; and 10 will receive 1250 mg twice a day of
nelfinavir (a protease inhibitor).
Patients in the two ritonavir groups (500-mg and 200-mg dose groups) took abacavir and
amprenavir for one week and then come to the clinic for blood tests to measure drug levels
before taking their morning pills and at 1/2, 1, 2, 4, 8, and 12 hours after taking the
medicines. They will then add ritonavir to their treatment regimen. After one week, they will
return for blood tests as before. They will then add efavirenz to their regimen and had
bloods drawn again after another 1 or 2 weeks.
Patients in the nelfinavir group took abacavir, amprenavir and nelfinavir for one week and
then have blood sampling as described above for the ritonavir group. They will then add
efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks.
Participants are being seen in the clinic for follow-up only if they wish to continue to
participate and if the regimen appears to offer clinical benefit.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)