Multicenter Open-Label, Randomized, Dose-Finding, Parallel-Group, Safety and Efficacy Trial of Subcutaneous Administration of Serostim in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS). - Full Text View

Multicenter Open-Label, Randomized, Dose-Finding, Parallel-Group, Safety and Efficacy Trial of Subcutaneous Administration of Serostim in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS).

This study has been completed.

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00294918

Purpose

This is an open label, multi-center, randomized, parallel group, maintenance trial of Serostim® in patients who have completed a prior Serostim® HARS trial. Assign patients who encountered toxicity during the antecedent protocol to a 1 mg dose. Randomize all others in a 1:1 ratio to receive up to 2 mg or 4 mg of Serostim®, beginning Day 1 of Week 1. Adjust doses downward in persons weighing <55 kg. Continue Serostim® therapy at the assigned dose through Week 12 (Period I). Assign patients who encounter toxicity during Period I to the 1 mg group for Period II. Randomize all other patients in a 1:1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Begin Period II therapy on Day 1 of Week 13, continuing through Week 36. Study Visits are required at Screen (i.e., Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.

Condition	Intervention	Phase
Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS) HIV Infections	Drug: recombinant human growth hormone (r-hGH)	Phase II Phase III

MedlinePlus related topics:

AIDS

Drug Information available for:

Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

In order to enroll in this continuation protocol, a patient must:
Complete all treatments prescribed by the antecedent protocol
Be able and willing to comply with the protocol for the duration of the study, including Concomitant Therapy restrictions
Have given written informed consent
If female, be post-menopausal, surgically sterile, or using adequate contraception

Exclusion Criteria:

A patient is ineligible to participate in this study if he/she:
Experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study
Withdrew from the antecedent study or was discontinued prematurely for any other reason, or
Based on the Final Visit evaluations from the antecedent trial, would be required to withdraw from the antecedent protocol, if (theoretically) the antecedent trial continued beyond the Final Visit.
Based on the Final Visit evaluations from the antecedent trial, would be required to temporarily stop or reduce the dose of study drug, if (theoretically) the antecedent trial continued beyond the Final Visit. This does not apply to patients whose study drug was temporarily stopped or whose study drug dose was reduced prior to the Final Visit (Screen), provided they continued in the antecedent protocol and are stable at the time of the Final Visit (Screen).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294918

Sponsors and Collaborators

EMD Serono

Investigators


Study Director:	Norma Muurahainen, M.D. PhD	EMD Serono

More Information

Related Info This link exits the ClinicalTrials.gov site

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Publications:

Low-dose Maintenance Therapy with Recombinant Human Growth Hormone Sustains Effects of Previous r-hGH Treatment in HIV+ Patients with Excess Center Fat: Treatment Results at 60 Weeks D P Kotler, C Grunfeld, N Muurahainen, C Wanke, M Thompson, D Bock, J Gertner, and Serostim in the Treatment of Adipose Redistribution Syndrome (STARS) Trial Investigator Group. Abstract. 11th Conference on Retroviruses and Opportunistic Infections. February 8-11, 2004, Moscone West, San Francisco CA, USA.

Study ID Numbers:	23056
First Received:	February 17, 2006
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00294918
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases

Signs and Symptoms

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Pathologic Processes

Disease

Slow Virus Diseases

Immune System Diseases

Syndrome

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 29, 2008