Mechanisms of Lipodystrophy in HIV-Infected Pateints

NCT00457665 | Completed Phase 4 Results DMC

• 1 other identifier: R01-56583
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; Lipodystrophy; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Effect of Drug Regimens on Serum Triglycerides.

  12 and 24 months

Study Arms (2)

Nelfinavir (Viracept)

ACTIVE COMPARATOR

Drug: Nelfinavir

Efavirenz (Sustiva)

ACTIVE COMPARATOR

Drug: Efavirenz

Interventions

Nelfinavir DRUG

Also known as: Viracept

Nelfinavir (Viracept)

Efavirenz DRUG

Efavirenz (Sustiva)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Bristol-Myers Squibb: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

HIV Infections; Lipodystrophy

Interventions

Nelfinavir; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Abhimanyu Garg
• Organization: UTSouthwestern Medical Center

abhimanyu.garg@utsouthwestern.edu

214-648-2895

Study Officials

• Abhimanyu Garg, M.D.

  University of Texas Southwestern Medical Center Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: February 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2014
• Last Updated: July 18, 2019
• Results First Posted: July 18, 2019

Record last verified: 2019-05

Locations

US (1)