Advertisement

Topics

A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving Since the Beginning and for, at Least, Two Years an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine

2014-08-27 03:12:18 | BioPortfolio

Summary

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.

Objectives:

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)].

Secondary objectives:

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.

Description

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).

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Conditions

HIV Infection

Status

Not yet recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:18-0400

Clinical Trials [270 Associated Clinical Trials listed on BioPortfolio]

The Epidemiology of Infection With Vancomycin-Resistant Enterococci

Current projects study veteran patients with chronic ulcers and MRSA colonization and infection, patients with imipenem-resistant P. aeruginosa colonization and infection, the relationship...

Diagnosis of Periprosthetic Joint Infection and the Common Pathogens, Durg-resistance in Periprosthetic Joint Infection

This retrospective study aims to improve the diagnosis of PJI as well as to identify microorganisms causing periprosthetic joint infection (PJI) and the drug-resistant spectrum

Antiretroviral Therapy for Acute HIV Infection

This is a protocol designed to provide HAART to subjects with acute HIV infection who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection co...

Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with "hyperacute" infection (estimated date of HIV infection w...

Study of Oral Papillomavirus In Teens and Twenties

Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil) cancer. But very little is known about oral HPV infection and risk factors. This study will eva...

PubMed Articles [6271 Associated PubMed Articles listed on BioPortfolio]

Frequency of occurrence of HIV-1 dual infection in a Belgian MSM population.

HIV-1 dual infection is a condition that results from infection with at least two HIV-1 variants from different sources. The scarceness of information on this condition is partly due to the fact that ...

Neurologic sequelae of primary HIV infection.

Primary human immunodeficiency virus type 1 (HIV-1) infection is defined as the period from initial infection with HIV to complete seroconversion. Neurologic sequelae of primary HIV-1 infection are no...

The role of procalcitonin in the management of pleural infection.

Pleural infection is a common problem associated with significant morbidity and mortality. Systemic or pleural fluid markers for reliably identifying pleural infection are limited. Procalcitonin (PCT)...

Acute HBV infection in humanized chimeric mice has multiphasic viral kinetics.

Chimeric uPA/SCID mice reconstituted with humanized livers are useful for studying HBV infection in the absence of an adaptive immune response. However, the detailed characterization of HBV infection ...

Defining Infection in Breast Reconstruction: A Literature Review.

Postoperative infection is the most common complications after implant-based immediate breast reconstruction (IBR), with reported rates ranging from less than 1% to 43%. This heterogeneity among the l...

Medical and Biotech [MESH] Definitions

Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.

A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.

Infection involving the tissues or organs in the PELVIS.

Infection in humans and animals caused by fungi in the class Zygomycetes. It includes MUCORMYCOSIS and entomophthoramycosis. The latter is a tropical infection of subcutaneous tissue or paranasal sinuses caused by fungi in the order Entomophthorales. Phycomycosis, closely related to zygomycosis, describes infection with members of Phycomycetes, an obsolete classification.

An infection at a specific location that may spread to another region of the body.

More From BioPortfolio on "A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving Since the Beginning and for, at Least, Two Years an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...

Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...


Searches Linking to this Trial