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.
Sponsor:
EMD Serono
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00294918
First received: February 17, 2006
Last updated: March 21, 2009
Last verified: March 2009
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by EMD Serono:
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 More Information
Additional Information:
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.
| ClinicalTrials.gov Identifier: | NCT00294918 History of Changes |
| Other Study ID Numbers: | 23056 |
| Study First Received: | February 17, 2006 |
| Last Updated: | March 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013