This will be a Phase II, randomized, partially placebo-controlled, 4-arm trial comparing amprenavir (APV) in a single-PI regimen versus APV in combination with saquinavir (SQVsgc), indinavir (IDV) or nelfinavir (NFV) in HIV-infected subjects currently failing IDV, RTV, SQV or NFV, as reflected by a plasma HIV-1 RNA concentration of >1000 copies/ml. Eligible subjects must be currently failing IDV, NFV, SQV, or RTV as part of a single or dual PI regimen (as evidenced by two consecutive plasma HIV RNA levels > 1000 copies/ml) after at least 16 cumulative weeks of protease inhibitor exposure. Subjects may have prior exposure to up to three protease inhibitors (IDV, RTV, SQV or NFV) including the currently failing regimen. For the purposes of this study, """"""""exposure"""""""" to a protease inhibitor is considered >7 cumulative days of treatment. No prior exposure to efavirenz (EFV), amprenavir (APV), abacavir (ABC) or adefovir dipivoxil (ADV) is allowed. Subjects with nevirapine or delavirdine exposure will be permitted to enroll but will be limited to 1.3 of the study population. Prior exposure to NRTIs is allowed. 460 subjects to be enrolled over a 6 month period. Subjects will be stratified for prior PI and NNRTI exposure. All subjects will receive amprenavir (APV), abacavir (ABC), efavirenz (EFV) and adefovir dipivoxil (ADV). Subjects will be selectively randomized to one of four treatment arms as described below. All subjects will have an equal or greater chance of being randomized to a dual-PI arm than the single-PI arm.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000750-27S3
Application #
6265140
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
27
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
Robinson-Cohen, Cassianne; Bartz, Traci M; Lai, Dongbing et al. (2018) Genetic Variants Associated with Circulating Fibroblast Growth Factor 23. J Am Soc Nephrol 29:2583-2592
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Kadakia, Kunal C; Kidwell, Kelley M; Seewald, Nicholas J et al. (2017) Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors. Breast Cancer Res Treat 164:411-419
Criado, Kristen K; Sharp, William G; McCracken, Courtney E et al. (2017) Overweight and obese status in children with autism spectrum disorder and disruptive behavior. Autism :1362361316683888
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
Zillikens, M Carola; Demissie, Serkalem; Hsu, Yi-Hsiang et al. (2017) Large meta-analysis of genome-wide association studies identifies five loci for lean body mass. Nat Commun 8:80
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048

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