Abstract

This is a phase III randomized, open-label, controlled trial of combination antiretroviral therapy. A total of 444 subjects nationwide will be enrolled. The study will be open to HIV-infected subjects with limited antiretroviral experience. Subjects will be randomized to one of three treatment arms and followed for at least 72 weeks beyond the enrollment of the last subjecgts. The three groups are (1) 3TC 150 mg/ZDV 300 mg BID + IDV 800 mg TID (control arm), (2) 3TC 150 mg/ZDV 300 mg BID + IDV 1000 mg TID + EFZ 600 mg QD, and (3) 3TC 150 mg/ZDV 300 mg BID + IDV 1000 mg TID + NFV 1250 BID. Other drugs will be available if patients experience virologic failure or relapse on these regimens. The CRC is essential for 3 of the 6 substudies. A Compartmental Substudy and Virologic Failure Substudy will evaluate the presence and type of HIV in lymph nodees and other tissues. An Intensive Pharmacokinetics/Pharmacodynamics Substudy will evaluate patients for systemic exposure of the drugs in Groups 1 and 3.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000037-39S1
Application #
6263554
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
1999
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

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