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Advanced Search Abstract Background. We compared 3 years of antiretroviral therapy with raltegravir or efavirenz as part of a combination regimen in the ongoing STARTMRK study of treatment-naive patients infected with human immunodeficiency virus HIV.
Outcomes included viral suppression, adverse events, and changes from baseline metabolic parameters. Dual energy X-ray absorptiometry scans were obtained on a convenience sample of patients at prespecified time points to assess changes in body fat composition.
At week counting noncompleters as failures, Consistent virologic and immunologic efficacy was maintained across prespecified demographic and baseline prognostic subgroups for both treatment groups. Both regimens were well tolerated, but raltegravir was associated with fewer drug-related clinical adverse events and smaller elevations in lipid levels.
NCT Raltegravir as part of combination antiretroviral therapy has proven efficacious and generally well tolerated in patients infected with human Com 156 week 3 virus type 1 HIV-1 susceptible or resistant to other classes of antiretroviral drugs [ 1—5 ].
Raltegravir recipients experienced fewer clinical adverse events than efavirenz recipients. As HIV treatment has evolved to a paradigm of lifelong therapy for many patients, often with comorbid conditions, long-term efficacy and safety data are essential to distinguish among antiretroviral regimens.
Accordingly, we analyzed the week results from STARTMRK, with particular attention to metabolic parameters including changes in lipid profiles and body fat composition. The protocol was approved by the Institutional Review Boards or Com 156 week 3 Review Committees at each site and conducted in accordance with Good Clinical Practice guidelines.
All participants provided written informed consent. The primary analysis was performed at week 48 as specified in the protocol. The trial was monitored by an independent Data and Safety Monitoring Board until 4 August after review of complete week data when the committee disbanded itself.
Continued double-blind follow-up is planned for a total duration of 5 years. After stratification, patients were randomly assigned in a 1: Participants were instructed to take tenofovir mg and emtricitabine mg coformulated as a single tablet Truvada in the morning with food, a mg tablet of raltegravir or matching placebo twice daily at approximately hour intervals without regard to food intake, and a mg tablet of efavirenz or identical placebo on an empty stomach at the hour of sleep.
To measure changes in body fat composition over time on study drugs, dual energy X-ray absorptiometry DEXA scans were to be obtained on a subset of patients from sites in the United States that had access to the necessary equipment at the baseline, week, week, and week visits.
Statistical Analyses All randomized and treated patients were included in the efficacy and safety analyses. This report presents efficacy results through week and all available safety data through 13 July the date when the last patient remaining in the study completed the week visit.
Primary and secondary analyses were specified at weeks 48 and 96, respectively, per protocol. Analyses of the nervous system adverse events and DEXA results were based on week data. Fasting blood samples were scheduled to be obtained at the week visit and compared with fasting baseline values.
An OF approach, which allowed evaluation of efficacy without confounding by discontinuations due to intolerability or other non—treatment-related reasons, was used for assessing changes from baseline CD4-cell counts and for the prespecified subgroup analyses based on demographic and prognostic factors at baseline.
Adverse events occurring during the double-blind phase of the study or within 14 days after discontinuation were included in this analysis.
Adverse events were considered to be drug-related if judged by the investigator as definitely, probably, or possibly related to any of the study drugs.
The intensity of clinical adverse events was graded by the investigator as mild, moderate, or severe. Severity of laboratory abnormalities was graded according to the DAIDS toxicity guidelines for adults.
For analysis of fasting lipid and glucose levels scheduled at the week visit, missing data were handled by carrying the last observation forward. If patients had initiated or increased the dosage of lipid-lowering therapy, the last available lipid value prior to the medication change was used in the analysis.
No missing data were imputed for the 2 analyses of body composition measurements by DEXA, based either on all available scans at each time point or only on scans available at both baseline and week Subject disposition through week is presented in Figure 1.
An additional 18 raltegravir recipients and 21 efavirenz recipients discontinued between week 96 and weekincluding 0 and 2 patients due to lack of efficacy, 2 and 3 patients because of adverse events, and 5 and 6 patients who did not enter the study extension at week 96 in the respective raltegravir and efavirenz groups.
Subsequent to their week visit but before the cutoff date for the present analysis, 2 more raltegravir recipients and 7 more efavirenz recipients left the study. At the cutoff date, the median [range] time on study was [8, ] and [2, ] weeks for the respective raltegravir and efavirenz groups, accounting for and person-years of treatment overall.
A total of 3 randomized patients, including 1 patient in the raltegravir arm and 2 patients in the efavirenz arm, never received study drugs. At the time the last remaining patient completed the week visit, 2 additional raltegravir recipients including 1 for an adverse event and 7 additional efavirenz recipients including 2 for an adverse event and 2 lost to follow-up had discontinued the study.Club, Forest Lake, Minnesota.
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