PMID- 19648823
OWN - NLM
STAT- MEDLINE
DCOM- 20091117
LR  - 20201209
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Linking)
VI  - 52
IP  - 3
DP  - 2009 Nov 1
TI  - Sustained antiretroviral effect of raltegravir after 96 weeks of combination 
      therapy in treatment-naive patients with HIV-1 infection.
PG  - 350-6
LID - 10.1097/QAI.0b013e3181b064b0 [doi]
AB  - OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of 
      raltegravir vs efavirenz-based antiretroviral therapy after 96 weeks in 
      treatment-naive patients with HIV-1 infection. METHODS: Multicenter, 
      double-blind, randomized study of raltegravir (100, 200, 400, or 600 mg twice a 
      day) vs efavirenz (600 mg every day), both with tenofovir/lamivudine (TDF/3TC), 
      for 48 weeks, after which raltegravir arms were combined and all dosed at 400 mg 
      twice a day. Eligible patients had HIV-1 RNA > or =5000 copies per milliliter and 
      CD4 T cells > or =100 cells per microliter. RESULTS: One hundred ninety-eight 
      patients were randomized and treated; 160 received raltegravir and 38 received 
      efavirenz. At week 96, 84% of patients in both groups achieved HIV-1 RNA <400 
      copies per milliliter; 83% in the raltegravir group and 84% in the efavirenz 
      group achieved <50 copies per milliliter (noncompleter = failure). Both groups 
      showed similar increases in CD4 T cells (221 vs 232 cells/uL, respectively). An 
      additional 2 patients (1 in each group) met the protocol definition of virologic 
      failure between weeks 48 and 96; no known resistance mutations were observed in 
      the raltegravir recipient; the efavirenz recipient had nucleoside reverse 
      transcriptase inhibitor and nonnucleoside reverse transcriptase inhibitor 
      resistance mutations. Investigator reported drug-related clinical adverse events 
      (AEs) were less frequent with raltegravir (51%) than efavirenz (74%). 
      Drug-related AEs occurring in >10% of patients in either group were nausea in 
      both groups and dizziness and headache in the efavirenz group. Laboratory AEs 
      remained infrequent. Raltegravir had no adverse effect on total or low-density 
      lipoprotein cholesterol or on triglycerides. Neuropsychiatric AEs remained less 
      frequent with raltegravir (34%) than efavirenz (58%). There were no drug-related 
      serious AEs in patients receiving raltegravir. CONCLUSIONS: In antiretroviral 
      therapy-naive patients, raltegravir with TDF/3TC had potent antiretroviral 
      activity, which was similar to efavirenz/TDF/3TC and was sustained to week 96. 
      Raltegravir was generally well tolerated; drug-related AEs were less frequent in 
      patients treated with raltegravir compared with efavirenz.
FAU - Markowitz, Martin
AU  - Markowitz M
AD  - Aaron Diamond AIDS Research Center, New York, NY, USA.
FAU - Nguyen, Bach-Yen
AU  - Nguyen BY
FAU - Gotuzzo, Eduardo
AU  - Gotuzzo E
FAU - Mendo, Fernando
AU  - Mendo F
FAU - Ratanasuwan, Winai
AU  - Ratanasuwan W
FAU - Kovacs, Colin
AU  - Kovacs C
FAU - Prada, Guillermo
AU  - Prada G
FAU - Morales-Ramirez, Javier O
AU  - Morales-Ramirez JO
FAU - Crumpacker, Clyde S
AU  - Crumpacker CS
FAU - Isaacs, Robin D
AU  - Isaacs RD
FAU - Campbell, Havilland
AU  - Campbell H
FAU - Strohmaier, Kim M
AU  - Strohmaier KM
FAU - Wan, Hong
AU  - Wan H
FAU - Danovich, Robert M
AU  - Danovich RM
FAU - Teppler, Hedy
AU  - Teppler H
CN  - Protocol 004 Part II Study Team
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Alkynes)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 0 (Pyrrolidinones)
RN  - 43Y000U234 (Raltegravir Potassium)
RN  - JE6H2O27P8 (efavirenz)
SB  - IM
MH  - Alkynes
MH  - Anti-HIV Agents/*administration & dosage/adverse effects/*therapeutic use
MH  - Benzoxazines/administration & dosage/adverse effects/therapeutic use
MH  - Cyclopropanes
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - HIV Infections/*drug therapy
MH  - *HIV-1
MH  - Humans
MH  - Pyrrolidinones/*administration & dosage/adverse effects/*therapeutic use
MH  - Raltegravir Potassium
FIR - Baker, D
IR  - Baker D
FIR - Bloch, M
IR  - Bloch M
FIR - Bodsworth, N
IR  - Bodsworth N
FIR - Cooper, D
IR  - Cooper D
FIR - Workman, C
IR  - Workman C
FIR - Tsoukas, C
IR  - Tsoukas C
FIR - Afani, A
IR  - Afani A
FIR - Perez, J
IR  - Perez J
FIR - Cortes, J
IR  - Cortes J
FIR - Mendo, F
IR  - Mendo F
FIR - Ratanasuwan, W
IR  - Ratanasuwan W
FIR - Thitivichianlert, S
IR  - Thitivichianlert S
FIR - Brown, S
IR  - Brown S
FIR - Galpin, J
IR  - Galpin J
FIR - Hicks, C
IR  - Hicks C
FIR - Kumar, P
IR  - Kumar P
FIR - Lichtenstein, K
IR  - Lichtenstein K
FIR - Little, S
IR  - Little S
FIR - Liporace, R
IR  - Liporace R
FIR - Santana-Bagur, J
IR  - Santana-Bagur J
FIR - Schwartz, R
IR  - Schwartz R
FIR - Steigbigel, R
IR  - Steigbigel R
FIR - Tashima, K
IR  - Tashima K
EDAT- 2009/08/04 09:00
MHDA- 2009/11/18 06:00
CRDT- 2009/08/04 09:00
PHST- 2009/08/04 09:00 [entrez]
PHST- 2009/08/04 09:00 [pubmed]
PHST- 2009/11/18 06:00 [medline]
AID - 10.1097/QAI.0b013e3181b064b0 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):350-6. doi: 
      10.1097/QAI.0b013e3181b064b0.