Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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HIV-Associated Lipodystrophy Syndrome Insulin Resistance HIV Infections Metabolic Syndrome X Body Weight Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rhGH + rosi

Recombinant human growth hormone + rosiglitazone

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone

Intervention Type DRUG

Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

rhGH placebo + rosi

Placebo for recombinant human growth hormone + rosiglitazone

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone

Intervention Type DRUG

Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

rhGH + rosi placebo

Recombinant human growth hormone + placebo for rosiglitazone

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone

Intervention Type DRUG

Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Double placebo

Placebo for recombinant human growth hormone + placebo for rosiglitazone

Group Type PLACEBO_COMPARATOR

Rosiglitazone

Intervention Type DRUG

4 mg tablet twice a day x 12 weeks (double-blind phase)

Recombinant human growth hormone + rosiglitazone

Intervention Type DRUG

Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Interventions

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Rosiglitazone

4 mg tablet twice a day x 12 weeks (double-blind phase)

Intervention Type DRUG

Recombinant human growth hormone + rosiglitazone

Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-infected
* On stable Food and Drug Administration (FDA)-approved antiretrovirals for at least 8 weeks
* Excess abdominal fat based on waist and hip measurements done at the screening visit. \[waist greater than 34.7 inches (men) or 29.6 inches (women) and waist to hip ratio greater than 0.95 (men) or 0.9 (women)\]
* Evidence of insulin resistance (based on fasting glucose and insulin levels done at screening)
* Triglycerides less than 750 mg/dL

Exclusion Criteria

* Pregnancy
* Active AIDS-defining infection or other acute illness, within 30 days of entry.
* Active cancer (except for localized Kaposi's sarcoma) or active brain tumor
* Any diagnosis of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorder associated with fluid retention (examples: cirrhosis, congestive heart failure)
* Untreated or uncontrolled high blood pressure, within 30 days of entry.
* Within 12 weeks of study entry, use of the following:

* Obesity (fat-reducing) drugs.
* Anti-diabetic or insulin-sensitizing drugs (examples: rosiglitazone, pioglitazone, or metformin).
* Systemic glucocorticoids (example: prednisone).
* Growth hormone or any medication for AIDS-associated wasting.
* Systemic chemotherapy, interferon, or radiation therapy.
* Androgenic agents \[examples: nandrolone, oxandrolone (Oxandrin) (testosterone replacement therapy is permitted if started more than 30 days before entry)\]
* Appetite stimulants (Marinol, Megace, Periactin).
* Use of cholesterol lowering drugs, unless started more than 12 weeks before entry
* Inability to have a magnetic resonance imaging (MRI) scan performed (examples: cardiac pacemaker, intracranial aneurysm clips)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No