Clinical Trials

• Therapeutic Drug Monitoring Study (Study # 5146)
• Study for HIV Treatment-Na?ve Subjects (Study # 5142)
• Antiretroviral Therapy Switching (Study # 5115)
• Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy (Study # 736)

AIDS Clinical Trials Unit
325-9th Avenue, Second Floor
Seattle WA 98104
(206) 731-3184
actu@u.washington.edu

Therapeutic Drug Monitoring Study (Study # 5146)

Purpose: to study the safety of increasing doses of protease inhibitor (PI) drugs based on Therapeutic Drug Monitoring.

• Needing to change 2nd, 3rd, or 4th anti-HIV drug regimen
• No serious illnesses
• Men and non-pregnant women

Study for HIV Treatment-Na?ve Subjects (Study # 5142)

Purpose: to examine the use of a lopinavir/ritonavir (a ritonavir-enhanced, second-generation protease inhibitor)-based regimen, a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, and a nucleoside-sparing regimen as the first treatment of HIV-1 infection.

• No prior antiretroviral therapy
• HIV RNA (viral load) of 2,000 copies or greater
• Planning to start anti-HIV treatment

Antiretroviral Therapy Switching (Study # 5115)

Purpose: to see and compare if it is better to change anti-HIV medications as soon as a viral load is 200 or wait until viral load is slightly higher. Changing medications at different viral load levels might matter in terms of 1) the immune system's ability to repair itself even if HIV viral load is not completely suppressed and 2) whether HIV is more or less likely to develop resistance if changes in medications are delayed.

• Taking antiretroviral medications for more than 4 months
• CD4 count of 200 or above
• HIV RNA less than 500 copies at one time and between 200 and 10,000 copies currently
• No severe medical conditions or infections
• Men and non-pregnant females

Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy (Study # 736)

Purpose: to see how levels of HIV in the blood compare to those in the cerebrospinal fluid (CSF) before and after treatment with potent antiretroviral therapy.

• Starting a new potent antiretroviral therapy (HAART) -- either starting as new therapy or changing current therapy
• No recent treatment for acute infection
• No active brain infection
• Men
• Women of childbearing potential must not be pregnant

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http://depts.washington.edu/actu