Abstract

This is a phase II, randomized, controlled trial of combination antiretroviral therapy to assess efficacy and safety of 4 regimens. Enrollees will be HIV-1-infected with prior antiretroviral experience, including 1-3 protease inhibitors (PIs), and have HIV RNA >1000 copies/mL on their current therapy. The treatment groups are: Group A: amprenavir (APV), saquinavir (SQV), abacavir (ABC), efavirenz (EFV) and adefovir dipivoxil (ADV); Group: APV, indinavir (IDV), ABC, EFV and ADV; Group C: APV, nelfinavir (NFV), ABC, EFV and ADV; Group D: APV, (protease inhibitor placebo), ABC, EFV and ADV. All subjects will receive L-carnitine supplementation (to offset adefovir's effect on carnitine). A total of 460 subjects nationwide and 10-20 locally will be enrolled. The CRC is essential for the Pharmacokinetic substudy, which is mandatory for the first 10 patients in each arm, and will also enroll 40 patients with virologic failure and 40 controls. This substudy will do complete pharmacokinetic profiles on day 14 for APV, EFV, ADV, and for SQV, IDV, or NFV in relevant subjects.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000037-42
Application #
6565629
Study Section
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
42
Fiscal Year
2002
Total Cost
Indirect Cost

  Institution

Name
University of Washington
Department
Type
DUNS #
135646524
City
Seattle
State
WA
Country
United States
Zip Code
98195

  Publications

Courcoulas, Anita P; King, Wendy C; Belle, Steven H et al. (2018) Seven-Year Weight Trajectories and Health Outcomes in the Longitudinal Assessment of Bariatric Surgery (LABS) Study. JAMA Surg 153:427-434
Field, Alison E; Inge, Thomas H; Belle, Steven H et al. (2018) Association of Obesity Subtypes in the Longitudinal Assessment of Bariatric Surgery Study and 3-Year Postoperative Weight Change. Obesity (Silver Spring) 26:1931-1937
O'Rourke, Robert W; Johnson, Geoffrey S; Purnell, Jonathan Q et al. (2018) Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes. Int J Obes (Lond) :
Cherrier, M M; Cross, D J; Higano, C S et al. (2018) Changes in cerebral metabolic activity in men undergoing androgen deprivation therapy for non-metastatic prostate cancer. Prostate Cancer Prostatic Dis 21:394-402
Duggan, Catherine; Baumgartner, Richard N; Baumgartner, Kathy B et al. (2018) Genetic variation in TNF?, PPAR?, and IRS-1 genes, and their association with breast-cancer survival in the HEAL cohort. Breast Cancer Res Treat 168:567-576
Han, Seung Jin; Boyko, Edward J; Kim, Soo Kyung et al. (2018) Association of Thigh Muscle Mass with Insulin Resistance and Incident Type 2 Diabetes Mellitus in Japanese Americans. Diabetes Metab J 42:488-495
Wander, Pandora L; Hayashi, Tomoshige; Sato, Kyoko Kogawa et al. (2018) Design and validation of a novel estimator of visceral adipose tissue area and comparison to existing adiposity surrogates. J Diabetes Complications 32:1062-1067
Purnell, Jonathan Q; Johnson, Geoffrey S; Wahed, Abdus S et al. (2018) Prospective evaluation of insulin and incretin dynamics in obese adults with and without diabetes for 2 years after Roux-en-Y gastric bypass. Diabetologia 61:1142-1154
King, Wendy C; Hinerman, Amanda S; Belle, Steven H et al. (2018) Comparison of the Performance of Common Measures of Weight Regain After Bariatric Surgery for Association With Clinical Outcomes. JAMA 320:1560-1569
Han, Seung Jin; Fujimoto, Wilfred Y; Kahn, Steven E et al. (2018) Change in visceral adiposity is an independent predictor of future arterial pulse pressure. J Hypertens 36:299-305

Showing the most recent 10 out of 563 publications