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ACTU New Clinical Trials

August 30, 2004


Study #1

Purpose of This Trial:

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:

  • CD4 cell count of at least 50 cells/mm3

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  • Viral load of at least 5,000 copies/ml

  • Current antiretroviral regimen must contain ritonavir for at least 8 weeks

  • Failure of at least one other antiretroviral regimen containing at least 3 drugs

  • No history of Hepatitis B or C

  • No history of seizures or recent trauma to the head with loss of consciousness

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.

Contact: Alyssa Spingola or Lori Cray at (206) 731-3184 spingola@u.washington.edu or lcray@u.washington.edu.


Study #2: Combination Therapy With Fish Oil and Fenofibrate for High Triglyceride Levels in Patients Receiving Highly Active Antiretroviral Therapy (HAART)

Purpose: 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]:

  • Arm A: Fish oil supplement 3 gm twice a day

  • Arm B: Fenofibrate 160 mg once a day

Phase 2:

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.

Study Treatment:

Fish oil supplement and fenofibrate are supplied. Antiretrovirals are NOT provided.

Eligibility (Requirements to Enter Study):

  • HIV positive men and women age 18 or older

  • Fasting triglycerides at least 400 mg/dL

  • LDL (low-density lipoprotein) 160 mg/dL or lower

  • HIV viral load 10,000 or lower

  • Receiving HAART for at least 3 months before study entry

  • On a lipid-lowering (low fat) diet and exercise program for at least 28 days before screening appointment (Self report is acceptable)

  • Not pregnant/breast-feeding

  • No History of coronary heart disease, congestive heart failure, peripheral vascular disease, stroke, diabetes or uncontrolled high blood pressure.

Compensation:

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.




  
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This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Ezine.
 
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