N/A
N=346
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
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT01159743 ↗Enrolled (actual)
346
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Total Limb Fat Mass — 8.84; 9.13 kg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Limb Fat Mass |
8.84; 9.13 | — |
| SECONDARY Distribution of Body Fat Mass |
20.13; 20.24; 10.77; 10.76; 2.11; 2.08 | — |
| SECONDARY Lipodystrophy Severity Grading Scale (LSGS) Scores |
1.02; 1.12; 0.98; 1.17; 2.01; 2.33 | — |
| SECONDARY Change Over Time in Body Fat Distribution |
-0.05; -0.06; 0.32; -0.05; 0.16; 0.10 | — |
Summary
The purpose of this study is to compare the body fat distribution in Human Immunodeficiency Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years, an antiretroviral therapy based on efavirenz or lopinavir/ritonavir and a combination of tenofovir plus emtricitabine (or lamivudine).
Eligibility Criteria
Inclusion Criteria
- Men and women aged ≥ 18 years with HIV-1 infection who are clinically stable and who were invited to participate in the study at a routine follow-up visit.
- HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial antiretroviral therapy (ART) based on efavirenz (EFV) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)] or HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial ART based on lopinavir/ritonavir (LPV/r) and a combination of TDF +FTC (or 3TC).
- Patients with an undetectable viral load, in response to the detection limit of each participating hospital defined in the last 6 months.
- Patients who have given written informed consent to participate in this study [personal data collection and performance of dual energy X-ray absorptiometry (DEXA)].
Exclusion Criteria
- Patients who have received at some point both efavirenz (EFV) and lopinavir/ritonavir (LPV/r) in combination regimen or thereafter.
- Patients who have had structured treatment interruptions (therapeutic holidays).
- Patients with a body mass index <16 kg/m^2.
- Patients with metallic prostheses or prosthetic material that could interfere with the measurement of dual energy X-ray absorptiometry (DEXA).
- Patients with a history of plastic or repair surgery in the buttocks and breasts.
- Patients with a diagnostic test with barium or radionucleotides, performed during the last month.
- Pregnant women.
- Patients treated with other agents under investigational phase.
- Patients on current treatment with systemic corticosteroids or chemotherapy.
- Diabetes mellitus and hypoglycaemic treatment.
- Transsexualism (though implicit in prostheses and drugs).
- Any drug taken chronically, which may alter the distribution of fat or adipocyte biology (insulin, non-steroidal anti-inflammatory drugs, etc).
- Patient has undergone liposuction.
Data sourced from ClinicalTrials.gov (NCT01159743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.