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. Author manuscript; available in PMC: 2009 Aug 4.
Published in final edited form as: Antivir Ther. 2009;14(4):543–549.

Appendix.

Parent AIDS Clinical Trials Group Protocols
Protocol Title Study Randomization Dates
384 Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor with Dual Nucleosides in Initial Therapy of HIV Infection 10/98 to 11/99
A5014 A Randomized, Open-Label, Pilot Treatment Trial Evaluating Cellular Dynamics and Immune Restoration in Treatment-Naive HIV-Infected Subjects Receiving Either the Protease Inhibitor LPV/r or the Nucleoside Reverse Transcriptase Inhibitors d4T/3TC/Abcavir with the Non-Nucleoside Reverse Transcriptase Inhibitor Nevirapine 3/00 to 3/01
A5095 Phase III, Randomized, Double-Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection 3/01 to 11/02
A5142 A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir plus Efavirenz vs. Lopinavir/Ritonavir plus 2 NRTIs vs. Efavirenz plus 2 NRTIs for the Initial Therapy for HIV-1 Infection 1/03 to 4/04
347 A Randomized, Double-Blind Phase 2 Study of VX-478 Monotherapy vs VX-478 plus ZDV plus 3TC in HIV Infected Individuals 3/97 to 6/97
388 A Phase III, Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination with Fixed-Dose Combination Lamivudine/Zidovudine (3TC/ZDV) and Indinavir (IDV) in HIV-Infected Subjects with <=200 CD4 Cells/MM3 or >= 80,000 HIV RNA Copies/m 6/98 to 1/99
364 Comparison of the Virologic Efficacy of Nelfinavir and/or DMP-266 in Combination with One or Two Nucleoside Analogs in Nucleoside Experienced Subjects: A Rollover Study of ACTG 302/303 7/97 to 9/97
372 A Phase II Study of the Prolongation of Virologic Success & Options for Virologic Failure in HIV-Infected Subjects Receiving IDV in Combination with Nucleoside Analogs: A Rollover Study to ACTG 320 10/97 to 1/98
373 An Open Label Phase II Study of Amprenavir (141W94/VX-478) Plus 3TC Plus ZDV or Indinavir Plus 3TC Plus d4T Plus NVP in Patients Previously Treated with Amprenavir (141W94/VX-478) (ACTG 347 Rollover Study) 11/97 to 4/98
398 A Phase II, Randomized Trial of APV as Part of Dual PI Regimens (Placebo Controlled) in Combination with ABC, EFV & ADV vs. APV Alone in HIV Infected Subjects with Prior Exposure to Approved PIs and Loss of Virologic Suppression as Reflected By A Plasma HIV-1 RNA of >= 1000 copies/ml 10/98 to 4/99
400 A Randomized, Open Label, Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals with Virological Evidence of Nelfinavir Treatment Failure 12/98 to 11/99
A5025 A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy with Less than 200 copies/ml of HIV RNA in the Plasma 11/98 to 5/99
A5064 A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy 3/00 to 5/01
A5076 HIV-1 Resistance Testing During Antiretroviral Failure: Comparison Of Sequencing versus Phenotyping 1/01 to 12/01
A5110 Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting 5/02 to 4/04
A5115 A Phase II Randomized, Controlled, Pilot Study of Antiretroviral Switch at Lower versus Higher HIV-1 RNA Levels in Subjects Experiencing Virologic Relapse on a Current HAART Regimen 9/02 to 4/04
A5126 A Phase II Study of the Predictive Value of Pharmacokinetic-Adjusted Phenotypic Susceptibility (C12h/IC50) on Antiretroviral Response to Ritonavir-Enhanced Protease Inhibitors in Subjects with Failure of Previous Protease Inhibitor-Based Regimensc 6/02 to 3/03
A5135 A Phase II, Randomized, Open-Label Study Comparing Fixed-Dose versus Concentration-Adjusted Lopinavir/Ritonavir Therapy in HIV-infected Subjects on Salvage Therapy 2/03 to 6/03
A5143 A Randomized, Comparative Study of LPV/RTV vs. GW433908 + RTV vs. LPV/RTV + GW433908 (in Combination with Tenofovir Disoproxil Fumarate and One or Two Nucleoside Reverse Transcriptase inhibitors) in HIV-1-Infected Subjects with Virologic Treatment Failure 10/02 to 7/03
A5146 A Phase II Randomized Controlled Trial Evaluating the Impact of Therapeutic Drug Monitoring (TDM) on Virologic Response to a Salvage Regimen in Subjects with a Normalized Inhibitory Quotient (NIQ) <= 1 to One or More Protease Inhibitors 12/02 to 5/06
A5211 Phase II, Randomized, Double-Blind Study of the Safety and Efficacy of SCH 417690 (an Orally Administered HIV-1 Entry Inhibitor) in HIV-Infected Treatment -Experienced Subjects 7/04 to 9/05