August 30, 2004
To evaluate the safety and effectiveness of three different dose levels of SCH 417690 (an investigational medication to treat (HIV-1), in HIV-infected individuals who are failing their current antiretroviral regimen (current regimen must contain ritonavir).
Requirements to Enter Study:
Medications While on Study:
Subjects will be randomized (like flipping a coin) to receive one of three SCH 417690 doses (5 mg, 10 mg, or 15 mg), or a look-alike placebo (does not contain any real medicine).
For the first 14 days, subjects will stay on their current failing regimen with the SCH 417690 or placebo added on.
After 14 days, can change background medications to an optimized regimen, which must contain ritonavir (not provided).
(SCH 417690 is an investigational medication.)
Length of Study: 48 weeks.
Visits involve a physical exam, questionnaires, EKG (screen, day 14, weeks 8, 24 and 48), peripheral neuropathy assessment (entry, weeks 24 and 48), and blood drawn from a vein in the arm.
Reimbursement: Exams, study medication (SCH 417690), and lab tests given at no cost. $20 for each on-study visit starting at entry.
To see whether the combination of fish oil and fenofibrate will lower the level of triglycerides (a fatty substance in the blood) in patients whose triglyceride levels are not responding to one of these agents alone.
Treatment Phase 1 [Patients are randomized (like flipping a coin) to receive either]:
At week 10, patients whose triglyceride levels are still higher than 200 mg/dL while only using one agent will begin a combination therapy with both the fish oil and fenofibrate.
Fish oil supplement and fenofibrate are supplied. Antiretrovirals are NOT provided.
Eligibility (Requirements to Enter Study):
Exams and study medications provided at no cost. $20.00 for each on-study visit starting at entry. For more information, please contact the ACTU at (206) 731-3184.