Document Detail


Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses.
MedLine Citation:
PMID:  20404738     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We analyzed the 96-week results in the overall population and in prespecified subgroups from the ongoing STARTMRK study of treatment-naive HIV-infected patients.
METHODS: Eligible patients with HIV-1 RNA (vRNA) levels >5000 copies per milliliter and without baseline resistance to efavirenz, tenofovir, or emtricitabine were randomized in a double-blind noninferiority study to receive raltegravir or efavirenz, each combined with tenofovir/emtricitabine.
RESULTS: At week 96 counting noncompleters as failures, 81% versus 79% achieved vRNA levels <50 copies per milliliter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 2% (-4 to 9), noninferiority P < 0.001]. Mean change in baseline CD4 count was 240 and 225 cells per cubic millimeter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 15 (-13 to 42)]. Treatment effects were consistent across prespecified baseline demographic and prognostic subgroups. Fewer drug-related clinical adverse events (47% versus 78%; P < 0.001) occurred in raltegravir than efavirenz recipients. Both regimens had modest effects on serum lipids and glucose levels and on body fat composition.
CONCLUSIONS: When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir exhibited durable antiretroviral activity that was noninferior to the efficacy of efavirenz through 96 weeks of therapy. Subgroup analyses were generally consistent with the overall findings. Both regimens were well tolerated.
Authors:
Jeffrey L Lennox; Edwin Dejesus; Daniel S Berger; Adriano Lazzarin; Richard B Pollard; Jose Valdez Ramalho Madruga; Jing Zhao; Hong Wan; Christopher L Gilbert; Hedy Teppler; Anthony J Rodgers; Richard J O Barnard; Michael D Miller; Mark J Dinubile; Bach-Yen Nguyen; Randi Leavitt; Peter Sklar;
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  55     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-08-24     Completed Date:  2010-09-16     Revised Date:  2014-02-06    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  39-48     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Anti-HIV Agents / adverse effects,  therapeutic use*
Antiretroviral Therapy, Highly Active / adverse effects,  methods*
Benzoxazines / adverse effects,  therapeutic use*
CD4 Lymphocyte Count
Female
HIV Infections / drug therapy*
HIV-1 / isolation & purification
Humans
Male
Middle Aged
Pyrrolidinones / adverse effects,  therapeutic use*
RNA, Viral / blood
Treatment Outcome
Viral Load
Young Adult
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Benzoxazines; 0/Pyrrolidinones; 0/RNA, Viral; 22VKV8053U/raltegravir; JE6H2O27P8/efavirenz
Investigator
Investigator/Affiliation:
D Cooper / ; J Madruga / ; E M Netto / ; R Zajdenverg / ; J G Baril / ; C Kovacs / ; F Smaill / ; A Afani / ; C Beltran / ; J Perez Godoy / ; A M Tobon / ; A Arango / ; J Tamara / ; J Velez / ; L Cotte / ; P-M Girard / ; G Pialoux / ; D Salmon-Ceron / ; Y Yazdanpanah / ; S Esser / ; G Fatkenheuer / ; J Rockstroh / ; R Schmidt / ; H-J Stellbrink / ; M Dinaker / ; A Pazare / ; J Rajendran / ; O Srivastava / ; G Carosi / ; A Chirianni / ; R Esposito / ; A Lazzarin / ; C Viscoli / ; J Andrade / ; N Quintero Perez / ; G Reyes / ; J Sierra / ; I Torres / ; E Gotuzzo / ; J Lama / ; R Cabello-Chavez / ; R Salazar / ; J Portilla Sogorb / ; A Rivero-Roman / ; J Santamaria Jauregui / ; W Manosuthi / ; S Sungkanuparph / ; K Supparatpinyo / ; A Vibhagool / ; D Berger / ; E DeJesus / ; T Friel / ; C Hicks / ; M Kozal / ; P Kumar / ; J Lennox / ; R Liporace / ; S Little / ; J Morales-Ramirez / ; R Novak / ; R Pollard / ; M Saag / ; S Santiago / ; S Schneider / ; R Steigbigel / ; W Towner / ; D Wright /
Comments/Corrections
Erratum In:
J Acquir Immune Defic Syndr. 2011 Dec 1;58(4):e120
Note: Dosage error in article text

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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