search
Back to results

Mechanisms of Lipodystrophy in HIV-Infected Pateints

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir
Efavirenz
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Lipodystrophy, Treatment Experienced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV Positive
  • No previous antiviral therapy
  • 18 to 70 years of age

Exclusion Criteria:

  • Patients with opportunistic infections or AIDS.
  • Active intravenous drug users.
  • Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace.
  • Patients with diabetes mellitus.
  • Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week).
  • Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).
  • Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL.
  • Anemia (hematocrit <32%).
  • Abnormal thyroid function tests.
  • Weight loss >10% from baseline in the past year.
  • Recent (within the past year), history of suicide attempt.

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nelfinavir (Viracept)

Efavirenz (Sustiva)

Arm Description

Outcomes

Primary Outcome Measures

Effect of Drug Regimens on Serum Triglycerides.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2007
Last Updated
May 8, 2019
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Bristol-Myers Squibb, GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00457665
Brief Title
Mechanisms of Lipodystrophy in HIV-Infected Pateints
Official Title
Mecahnisms of Lipodystrophy in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Bristol-Myers Squibb, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear. The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.
Detailed Description
A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Lipodystrophy, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nelfinavir (Viracept)
Arm Type
Active Comparator
Arm Title
Efavirenz (Sustiva)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nelfinavir
Other Intervention Name(s)
Viracept
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Primary Outcome Measure Information:
Title
Effect of Drug Regimens on Serum Triglycerides.
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV Positive No previous antiviral therapy 18 to 70 years of age Exclusion Criteria: Patients with opportunistic infections or AIDS. Active intravenous drug users. Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace. Patients with diabetes mellitus. Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week). Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry). Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL. Anemia (hematocrit <32%). Abnormal thyroid function tests. Weight loss >10% from baseline in the past year. Recent (within the past year), history of suicide attempt.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhimanyu Garg, M.D.
Organizational Affiliation
University of Texas Southwestern Medical Center Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mechanisms of Lipodystrophy in HIV-Infected Pateints

We'll reach out to this number within 24 hrs