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Hormone Therapy

Therapeutic Approaches to HAART-Induced Lipodystrophy

Phase 2
Waitlist Available
Led By Abhimanyu Garg, M.D.
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved

Summary

To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.

Eligible Conditions
  • Lipodystrophy
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LeptinActive Control1 Intervention
Leptin weight and gender based dose, sub-cutaneous, twice daily. Leptin versus placebo for entire 6 months double-blind.
Group II: PlaceboPlacebo Group1 Intervention
Placebo , sub-Q injection twice daily.

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,660 Total Patients Enrolled
7 Trials studying Lipodystrophy
133 Patients Enrolled for Lipodystrophy
Amylin Pharmaceuticals, LLC.Industry Sponsor
40 Previous Clinical Trials
1,839 Total Patients Enrolled
1 Trials studying Lipodystrophy
4 Patients Enrolled for Lipodystrophy
Abhimanyu Garg, M.D.Principal InvestigatorUniveristy of Texas Southwestern Medical Center
3 Previous Clinical Trials
82 Total Patients Enrolled
2 Trials studying Lipodystrophy
74 Patients Enrolled for Lipodystrophy
~1 spots leftby Jan 2026
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