Growth Hormone in the Treatment of HIV-Associated Wasting

NCT00489528 | Completed Phase 3

• 1 other identifier: 9037
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug.

Conditions

HIV Infections; HIV Wasting Syndrome

Keywords

serostim; Dose-Response Relationship, Drug; Body Composition

Outcome Measures

Primary Outcomes (1)

• To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.

Secondary Outcomes (1)

• To establish an optimal dose of Serostim, based on the endpoint of lean body mass (LBM) change.

Interventions

Somatropin; Recombinant human growth hormone (r hGH) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have clearly documented HIV infection, determined by the presence of HIV confirmed by one of the following: Western blot, immunofluorescence assay, HIV culture, polymerase chain reaction (PCR) amplification, branched DNA (bDNA) signal amplification or the presence of p24 antigen. These tests may have been performed at any time in the past, but the results must be available for review by Serono prior to entry into the study.
• Have evidence of AIDS wasting, with at least one of the following:
• Documented unintentional weight loss of at least 10%, or
• In the absence of unintentional weight loss of 10%, weight less than 90% of ideal body weight (Metropolitan Height and Weight Tables), or
• In the absence of unintentional weight loss of 10%, body mass index \< 20 kg/m².
• Be at least 18 years of age.
• Be receiving at least 90% of estimated caloric requirement on current nutritional regimen, according to a formal nutritional analysis.
• Meet the following laboratory testing criteria at the week -4 visit (pre study screening):
• AST, ALT, and amylase \< 3 times the upper limit of normal.
• Fasting triglyceride level \< 500 mg/dl (or \<5.64 mmol/l).
• Fasting glucose \< 110 mg/dl (or \< 6.1mmol/l).
• Be taking an antiretroviral medication that is approved or available under a Treatment IND (in the US) or a temporary approval (outside the US).
• The subject must have been on the antiretroviral therapy for at least 8 weeks prior to study Day 1.
• The subject must agree not to change the antiviral regimen during the 12 weeks of study drug administration (unless medically mandated).
• Be capable of completing all required study activities and assessments (including all required exercise performance tests).

You may not qualify if:

• Any medical history of the following:
• Pancreatitis.
• Carpal tunnel syndrome (unless resolved by surgical release).
• Glucose intolerance \[for the purpose of this protocol defined as fasting blood glucose ≥ 110 mg/dl (6.1 mmol/l), or 2 hour/random blood glucose ≥ 140 mg/dl (7.8 mg/dl)\].
• Angina pectoris.
• Coronary artery disease.
• Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure, lymphedema).
• Allergy or hypersensitivity to growth hormone.
• Any of the following medical conditions:
• Active AIDS-defining opportunistic infection.
• Any active malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which exceeds 2 cm in size, not on active therapy).
• A central nervous system (CNS) mass, or CNS process associated with active neurological findings.
• Chronic diarrhea (defined as 6 or more liquid stools per day).
• Unstable or untreated hypertension.
• Patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure.

Sponsors & Collaborators

• EMD Serono: lead

MeSH Terms

Conditions

HIV Infections; HIV Wasting Syndrome

Interventions

Human Growth Hormone; Growth Hormone

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; Wasting Syndrome; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elizabeth Svanbert, MD, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: July 1, 1997
• Study Completion: March 1, 2002
• Last Updated: October 22, 2013

Record last verified: 2013-10