ACRIA Studies in Progress

• Tipranavir Open Label Safety Study
• The Effect of Reyataz on Cholesterol Levels
• Reyataz Compared to Kaletra
• Phase I Study of a New GlaxoSmithKline NNRTI
• Standard of Care Treatment vs. ZEST Once-Daily Regimen

Tipranavir Open Label Safety Study

People whose virus has become resistant to approved HIV treatments or who are intolerant to them will take tipranavir with Norvir, along with other anti-HIV drugs, for an open period of time. You must be 13 years of age or older, have a viral load above 10,000 and a CD4 count below 100 to enroll in this program.

The Effect of Reyataz on Cholesterol Levels

People who have high cholesterol levels and a viral load below 50 while taking Kaletra will either switch to Reyataz or continue taking Kaletra. The study will last 11 months. Study participants will be reimbursed $25 for each visit.

Reyataz Compared to Kaletra

People whose viral load has risen to over 1,000 on two separate tests while taking an NNRTI will switch to either Kaletra, or to Reyataz/Norvir. Everyone will also take Viread and either Videx EC or Zerit XR. The study will last for 22 months. Study participants will be reimbursed $25 for each visit.

Phase I Study of a New GlaxoSmithKline NNRTI

People who have never taken anti-HIV medications before will take one of four doses of W695634G alone or take placebo pills for 10 days. Participants who complete the study will be reimbursed $900. Opening in May of 2004.

Standard of Care Treatment vs. ZEST Once-Daily Regimen

This trial will study whether people on their first HAART regimen who take their drugs two or more times a day can switch to a once-daily regimen. People in the trial will either remain on their current medications, or switch to Zerit XR, Epivir and Sustiva (ZEST) taken once daily. They will visit ACRIA nine times over 11 months. You are eligible if you are HIV-positive, age 18 or over, and on an initial HAART regimen (one or more NRTIs, at least one agent must have a twice-daily dosing schedule, and no NNRTI in the past or in current regimen) with a viral load below 50. Study participants will be reimbursed $25 for each visit.

For the above trials, contact Dr. Douglas Mendez at 212-924-3934 ext. 126 or Dr. Yuriy Akulov at 212-924-3934 ext. 124.