Abstract

ACTG 384 is a six-arm double blinded study designed to examine the optimal initial regimen in antiretroviral-naive subjects (with plasma HIV-1RNA levels >500 copies/ml.) using 3-or-4 drug regimens. Sequential triple combination therapy (Arms A,B,C,D) will be evaluated in subjects who fail initial therapy by assigning the subject to a regimen that includes a different double necleoside analog reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) or nelfinavir(NFV), whichever they were not receiving. Two 4-drug regimens containing double NRTIs with both EFV and NFV will also be evaluated. A major effort will be made to examine pharmacologic and adherence factors, as well as virologic and immunologic factors, that may contribute to virologic failure. The design of ACTG 384 allows the opportunity to examine subjects receiving two consecutive antiretroviral regimens, and for four of the six arms, a third salvage regimen.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-39
Application #
6441930
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
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
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
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
Gibson, Kelly S; Stark, Sydney; Kumar, Deepak et al. (2017) The relationship between gestational age and the severity of neonatal abstinence syndrome. Addiction 112:711-716

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