Growth Hormone in the Treatment of HIV-Associated Wasting
Information provided by (Responsible Party)
First received: June 20, 2007
Last updated: October 21, 2013
Last Verified: October 2013
History of Changes
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.
HIV Wasting Syndrome
Drug : Somatropin; Recombinant human growth hormone (r hGH)
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Recombinant Human Growth Hormone (Serostim) in the Treatment of HIV-Associated Catabolism/Wasting|
Further study details as provided by EMD Serono:
Primary Outcome Measures
- To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.
- To establish an optimal dose of Serostim, based on the endpoint of lean body mass (LBM) change.
|Study Start Date:||July 1997|
|Study Completion Date:||March 2002|
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
- 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
- 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).
- Understand and sign an informed consent document.
- 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.
- 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.
- New systemic therapy for opportunistic infection.
- New therapy for wasting, including parenteral or oral hyperalimentation, tube feeding, anabolic or progestational agents, or appetite stimulants.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489528
Sponsors and CollaboratorsEMD Serono
|Study Director:||Elizabeth Svanbert, MD, PhD|
|Responsible Party:||EMD Serono|
|ClinicalTrials.gov Identifier:||NCT00489528 History of Changes|
|Other Study ID Numbers:||9037|
|Study First Received:||June 20, 2007|
|Last Updated:||October 21, 2013|
Keywords provided by EMD Serono:serostim
Dose-Response Relationship, Drug
Additional relevant MeSH terms:
HIV Wasting Syndrome
ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.