Table 1.

Description of Relevant Parent Studies

Protocol	Protocol title	Study population	Study regimen	Total Sampl e size	# of cases (controls ) used in analysis	Time Period
34725	A Randomized, Double-Blind Phase 2 Study of APV Monotherapy vs APV plus ZDV plus 3TC in HIV-Infected Individuals	PI and 3TC naïve HIVinfected subjects	Arm 1: APV + ZDV + 3TC Arm 2: APV + ZDV placebo + 3TC placebo	92	1 (1)	12/13/1996 - 05/01/2000
36426	Comparison of the Virologic Efficacy of Nelfinavir and/or Efavirenz in Combination with Two Nucleoside Analogs in Nucleoside Experienced Subjects: A Rollover Study of ACTG 302/303	NRTI therapy experienced, but HAART naïve HIVinfected subjects	Arm I: NFV + EFV placebo Arm II: NFV placebo + EFV Arm III: NFV + EFV Plus 2 NRTI	237	7 (9)	05/15/1997 - 12/01/2006
372A27	A Phase II Study of the Prolongation of Virologic Success & Options for Virologic Failure in HIVInfected Subjects Receiving IDV in Combination with Nucleoside Analogs: A Rollover Study to ACTG 320	HIV-infected subjects who were virologically suppressed on IDV+ZDV (or d4T) + 3TC regimen	Arm 1: IDV + ZDV + 3TC + ABC Arm 2: IDV + ZDV + 3TC + ABC placebo	299	6 (11)	07/22/1997 - 06/28/2003
38428	Study of Protease Inhibitor and/or Non- Nucleoside Reverse Transcriptase Inhibitor with Dual Nucleosides in Initial Therapy of HIV Infection	HIV-infected antiretroviralnaive subjects (defined as <7 days of prior antiretroviral therapy) with plasma HIV-1 RNA levels ≥ 500 copies/mL	Arm A: ddI + d4T + EFV + NFV placebo Arm B: ddI + d4T + EFV placebo + NFV Arm C: 3TC/ZDV + EFV + NFV placebo Arm D: 3TC/ZDV + EFV placebo + NFV Arm E: ddI + d4T + EFV + NFV Arm F: 3TC/ZDV + EFV + NFV	987	18 (32)	08/24/1998 - 11/03/2002
38829	A Phase III Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination with Fixed-Dose Combination Lamivudine/Zidovudi ne (3TC/ZDV) and Indinavir (IDV) in HIV-infected Subjects with <200 CD4 cell/mm3 or > 80,000 HIV RNA copies/mL in Plasma	HIV-infected subjects with limited (no prior 3TC, NNRTI, or protease inhibitor) or no prior antiretroviral treatment and ≤ 200 CD4 cells/mm3 or 80,000 HIV RNA copies/mL of plasma	Arm 1: 3TC/ZDV + IDV Arm 2: 3TC/ZDV + IDV + EFV Arm 3: 3TC/ZDV + IDV + NFV	517	16 (31)	02/16/1999 - 10/15/2005
39830	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	Subjects failing IDV, NFV, SQV, or RTV as part of a single- or dual-PI regimen	Arm 1: APV + SQV + ABC + EFV +ADV Arm 2: APV + IDV + ABC + EFV + ADV Arm 3: APV + NFV + ABC + EFV + ADV Arm 4: APV + PI placebo + ABC + EFV +ADV	481	41 (74)	07/31/1998 - 05/01/2000
A502531	A Phase II Randomized Study of the Safety and Efficacy of Hydroxyurea in Patients on Potent Antiretroviral Therapy with Less than 200 copies/mL of HIV RNA in the Plasma	HIV-infected subjects with suppressed viral load after having received at least six (6) months of IDV, ZDV (or d4T) and 3TC	Arm A: IDV + ddI + d4T + HU placebo Arm B: IDV + ddI + d4T + HU Am C: IDV + 3TC/ZDV (or d4T + 3TC)	207	1 (1)	08/31/1998 - 08/01/2004
A509532	Phase III, Randomized, Double- Blind Comparison of Three Protease Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection	Antiretroviral -naive subjects aged 16 and over with HIV-1 RNA ≥ 400 copies/mL	Arm A: ABC/3TC/ZD V + 3TC/ZDV placebo + EFV Arm B: ABC/3TC/ZD V Placebo + 3TC/ZDV + EFV Arm C: ABC/3TC/ZD V + 3TC/ZDV placebo +EFV placebo	1147	14 (24)	12/22/2000 - 06/29/2005

KEY: 3TC = lamivudine ABC = abacavir ADV = adefovir APV = amprenavir d4T = stavudine ddI = didanosine EFV = efavirenz HAART = highly active antiretroviral therapy HU = hydroxyurea IDV = indinavir NFV = nelfinavir NRTI = nucleoside reverse transcriptase inhibitor NNRTI = nonnucleoside reverse transcriptase inhibitor PI = protease inhibitor RTV = ritonavir SQV = saquinavir ZDV = zidovudine