University of Washington AIDS Clinical Trials Unit -- Open Winter 2003

Complications of HIV and Other Conditions Studies

Study #5082: Lowering Blood Insulin and Body Fat
Length: 32 weeks (about 8 months)

• Treatment: Metformin and Rosiglitazone or Metformin placebo and Rosiglitazone or Metformin and Rosiglitazone placebo or Metformin placebo and Rosiglitazone placebo.

• Eligibility: HIV+ • age 18-65 • Increased waist size • HIV RNA (viral load) less 10,000 • on stable ARV and not planning to change • No prior use of anti-diabetic medications.

• Compensation: $25 paid for each CT or DEXA scan and $20 for each study visit.

Study #5090: HIV-Associated Dementia
Length: 24 weeks with optional 24-week extension

• Treatment: Selegiline Transdermal System (STS patch) vs. OR STS patch placebo.
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• Eligibility: HIV+ • Age 18+ • Males and non-pregnant females • Documented HIV dementia • on stable ARV drugs e more than 8 weeks • No current mental illness.

• Compensation: All subjects offered STS at 24th week. $20-100 paid for some tests.

Study #5084: Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-infected Pregnant Women
Length: 38 weeks

• Treatment: Anti-HIV medications will not be not be provided on this study.

• Eligibility: HIV+ • Taking PIs 8 weeks prior to study entry or not taking a PI 8 weeks prior to study entry Between 20-34 weeks pregnant • No history of diabetes (except prior history of diabetes during pregnancy) • 13 years of age or older • No major fetal anomaly as diagnosed by ultrasound • No major complications during current pregnancy.

• Compensation: $20 for visits/exams and lab tests given at no cost.

Study #5092: Drug-Drug Interactions in HCV
Length: Approx 8 weeks

• Treatment: Ribavirin prescribed by other health care provider.

• Eligibility: HIV+ • HCV+ • 13+ years of age • CD4 >100 • On AZT or d4T at least 4 weeks prior to entry • Planning to start Ribavirin • No Ribavirin for at least 6 months prior to entry.

• Compensation: $150 paid for each of 2 10-hour clinic visits (one at entry, and another at week 8).

Study #736: HIV in Cerebrospinal Fluid
Length: 48 weeks

• Treatment: None.

• Eligibility: CD4 cell count 200 or less cells/mm³ • HIV RNA 2000+ copies/ml or HIV RNA 50,000+ with any CD4 count • Starting or changing antiretroviral therapy.

• Compensation: $100-$125 for each lumbar puncture (3).

Study #079: HIV in the Lungs
Length: 1-2 visits

• Treatment: None.

• Eligibility: HIV+ • HIV RNA <50 copies/mL.

• Compensation: $25 for sputum sample.

Physicians or potential participants can call Alyssa or Loni at 206-731-3184 for information or appointments. Screening tests, study medications, laboratory, and clinical monitoring that are part of a study are provided free of charge.

Antiretroviral Studies Open to Enrollment-Winter 2003

Study #5073: Comparing Twice Daily and Once-Daily and Comparing Self-Administered Therapy and Direct Observation Therapy
Length: 1 year

• Treatment: Group #1: LPV/r + FTC + d4t twice a day (almost all doses taken outside the clinic) • Group #2: LPV/r + FTC + d4t once a day (almost all doses taken outside the clinic • Group #3: LPV/r + FTC + d4t once a day (almost all doses observed by a health care worker).

• Eligibility: HIV+ • age 13+ • No prior antiretrovirals • No severe Medical Conditions • Men and non-pregnant women.

• Compensation: $20 per study visit plus $5 for DOT meeting.

Study #5029: New!! HPV and HIV in ARV-Inexperienced Women
Length: 3-5 years

• Treatment: None. ARV (Antiretroviral therapy) prescribed by another physician or primary health care provider.

• Eligibility: HIV infection • age 13+ • Have taken no anti-HIV meds in the past but now starting • Must not have had cervical cancer in the past.

• Compensation: $20 for study visit. Study includes brief pelvic exams, pap smears, and blood draws. Subjects with abnormal pap smears will have a colposcopy.

Study #5043: Drug Levels in HIV-Negative Persons
Length: 6 weeks/3 weeks on drugs

• Treatment: Efavirenz for 10 days; Add APV for 3 days; Add a third drug (IDV, NFV, RTV, or SQV) for 1 week in 80% of enrollees.

• Eligibility: HIV- • 18-65 years • Males; females not able to become pregnant • No chronic illnesses • No chronic medications.

• Compensation: 3 inpatient visits plus follow-up visit reimbursed at $150 each.

Study #5143: LPV/r and GW433908 Alone or Together in Addition to TDF Plus 1 or 2 NRTIs
Length: 1 year

• Treatment: LPV/r + TDF +1 or 2 NRTIs OR GW433908 + RTV+ TDF+ 1or 2 NRTIs OR LPV/r + GW433908 + TDF + 1 or 2 NRTIs.

• Eligibility: HIV+ • 18+ years of age • use of at least 1 PI-containing regimen for 12 weeks min. that has changed or will due to virological failure or detectable plasma HIV-1RNA % min 1 year anti-HIV drug experience • HIV RNA >5,000 copies/mL • Non-pregnant or breast feeding females • No prior use of lopinavir or amprenavir.

• Compensation: $10 per study visit; $100 for sub-study visit.

Study #5093: Effects of ARVs on Depo Provera
Length: 12 weeks

• Treatment: Will receive one injection of Depo-Provera • No ARVs provided by study.

• Eligibility: HIV+ women • age 13+ years • On no ARVs and CD4 >200 • On EFV, NVP, NFV, or IDV/RTV and CD4 <350 • HIV RNA <10,000.

• Compensation: 2 inpatient visits for most subjects-provides reimbursement.