Mechanisms of Lipodystrophy in HIV-Infected Pateints

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00457665
• Date of registration: 04/04/2007
• Prospective Registration: No
• Primary sponsor: University of Texas Southwestern Medical Center
• Public title: Mechanisms of Lipodystrophy in HIV-Infected Pateints
• Scientific title: Mecahnisms of Lipodystrophy in HIV-Infected Patients
• Date of first enrolment: February 2002
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00457665
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Abhimanyu Garg, M.D.
• Affiliation: University of Texas Southwestern Medical Center Dallas

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Efavirenz

Drug: Nelfinavir

Primary Outcome(s)

Effect of Drug Regimens on Serum Triglycerides. [Time Frame: 12 and 24 months]

Secondary ID(s)

R01-56583

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 18/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00457665