Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Condition: HIV-Associated Lipodystrophy Syndrome; Insulin Resistance; HIV Infections; Metabolic Syndrome X; Body Weight Changes
MeSH terms: HIV-Associated Lipodystrophy Syndrome; Lipodystrophy; Metabolic Syndrome; Insulin Resistance; Syndrome; Body Weight; Body Weight Changes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine if the combination of recombinant human growth
      hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than
      either drug alone (or no active therapy) for the treatment of fat accumulation in people with
      HIV infection and insulin resistance.
    

Detailed description: 
      A number of people with HIV infection who gain weight in the abdomen (sometimes called
      lipodystrophy) also have a high level of the sugar-controlling hormone called insulin. These
      people need to produce this extra insulin to help keep their blood sugar normal. This is
      called "insulin resistance."

      Studies have shown that growth hormone (also called "Serostim") can decrease abdominal fat,
      but it can also worsen the insulin resistance. Rosiglitazone (also called "Avandia") is used
      to treat insulin resistance in people who have diabetes, so we want to see if taking growth
      hormone and rosiglitazone together will be better for treating the fat accumulation part of
      lipodystrophy than either drug alone or no active therapy.

      The study is 24 weeks long, divided into two 12-week parts.

      The first part of the study is double-blind, meaning that neither participants nor the study
      staff will know which drugs participants are on. Participants will be assigned randomly (like
      flipping a coin) to one of four groups:

        1. Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily).

        2. Growth hormone PLUS rosiglitazone placebo ("sugar pill").

        3. Growth hormone placebo (plain water injection) PLUS rosiglitazone.

        4. Growth hormone placebo PLUS rosiglitazone placebo.

      Everyone in the study will need to be hospitalized overnight for special tests at the
      beginning of the study and at week 12.

      The second part of the study is open-label, meaning that participants and the study staff
      will know which drugs participants are receiving. All volunteers will receive both active
      drugs:

        -  Growth hormone (one 2 mg injection, every other day) PLUS rosiglitazone (one 4 mg
           tablet, twice daily).
    

Intervention name(s): Rosiglitazone; Recombinant human growth hormone + rosiglitazone
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg tablet twice a day x 12 weeks (double-blind phase); Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
Intervention MeSH terms: Rosiglitazone; Hormones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lipodystrophy; HIV; Growth hormone; Rosiglitazone; Visceral fat; Metabolic syndrome; Treatment Experienced; Visceral fat accumulation; fat accumulation; HIV-Associated Metabolic Syndrome