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Hypothesis: According recently published data from ACTG 5142 study, lipoatrophy was more frequent with Efavirenz (EFV) than Lopinavir/ritonavir (LPV/r) in the presence of the same pair of nucleoside analog reverse transcriptase inhibitors (NRTIs). It was also more frequent with stavudine-containing regimens and less frequent with tenofovir-containing regimens.
We intend to demonstrate that human immunodeficiency virus-1 (HIV-1) infected patients receiving exclusively non-thymidine NRTIs regimen [didanosine (ddI), zalcitabine (ddc), lamivudine (3TC), abacavir (ABC), emtricitabine (FTC), tenofovir (TDF)] with LPV/r as anchor have less or, at least a minor grade, of lipoatrophy versus HIV-1 infected patients receiving non-thymidine analogs regimen (ddI,ddc, 3TC,ABC, FTC,TDF) with EFV as anchor.
To compare mean limb fat, as measured by dual energy X-ray absorptiometry (DEXA), in HIV-1 infected patients receiving since the beginning and for at least two years initial antiretroviral therapy (ART) based on efavirenz (EFV) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)] versus lopinavir/ritonavir (LPV/r) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)].
1. To compare mean trunk fat, as measured by DEXA, in HIV-1 infected patients receiving since the beginning and for at least two years initial antiretroviral treatment (ART) based on efavirenz (EFV) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)] versus lopinavir/ritonavir (LPV/r) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)].
2. To compare body fat distribution (limb and trunk) in patients measured by dual energy x-ray absorptiometry ( DEXA) to patient self-perception using the Lipodystrophy Severity Grading Scale (LSGS).
3. To compare body fat (limb and trunk) distribution in patients measured by DEXA to physician perception based on the LSGS.
4. To correlate fat distribution in patients as perceived by patients themselves and by physicians based on the LSGS.
5. In patients for whom a DEXA measurement performed at least 12 months before participation in this study is available, change over time in fat will be compared between treatment groups.
6. To assess the factors associated with development of lipoatrophy perceived by patients according the LSGS.
7. If an index is available for diagnosing lipoatrophy based on data obtained from DEXA and/or clinical or anthropometric parameters of patients, we intend to use it to compare the proportion of patients with lipoatrophy according to this index in each treatment group.
Post-authorization; observational, national, multicenter, comparative, cross-sectional study.
PATIENT SELECTION Patients will be randomly selected based on the recruitment potential of each site according to the following criteria: type of antiretroviral treatment (ART), time on ART, human immunodeficiency virus and hepatitis C Virus (HIV-HCV) co-infection, and patient sex (male or female).
For this random selection, each participating site will previously be sent a table designed to record the patient potential based on these criteria. This table will be sent to a central control. The centralized control will be responsible for random selection from this listing, assigning a code for this study to each patient.
A selected patient who refuses to participate in the study may be replaced with one that meets the same criteria: such as type of ART, time under ART, HIV-HCV co-infection and gender. Patients from the random selection, who have refused entry to the study, will be recorded together with the reasons given for not participating.
PLANNED NUMBER OF SUBJECTS In order to prove the null hypothesis of equal means in both populations, a 0.05 significance criterion (alpha) and a two-tailed test will be used. With the proposed sample size of 510 patients (255 in each study group), the study will have an 80% power for detecting a difference of at least 0.5 kg limb fat between the means of the two study groups with a common group standard deviation of 2.0.
MAIN DATA COLLECTED Apart dual energy X-ray absorptiometry (DEXA) report and routine visit clinical results, demographic and clinical basic information will be collected.
Also other data related to comorbidities (presence or absence of diabetes, high blood pressure, coronary arteriopathy, ictus, hyperlipoproteinemia, HCV coinfection-Hepatitis B Virus coinfection); concomitant medication (statins, fibrates, insulin, oral hypoglycemic drugs).
Observational Model: Cohort, Time Perspective: Cross-Sectional
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:12:18-0400
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