Status:
COMPLETED
An Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome
Lead Sponsor:
EMD Serono
Conditions:
Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
Human Immunodeficiency Virus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is an open-label, multi-center, randomized, parallel-group, maintenance trial of Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency Virus-associated Adipose Redistr...
Eligibility Criteria
Inclusion
- Complete all treatments prescribed by the antecedent protocol (Study 22388)
- 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
- Experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study (Study 22388)
- Withdrew from the antecedent study or was discontinued prematurely for any other reason
- 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 subjects whose study drug was temporarily stopped or whose study drug dose was reduced prior to the Final Visit (Screening), provided they continued in the antecedent protocol and are stable at the time of the Final Visit (Screening)
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00294918
Start Date
September 1 2001
End Date
February 1 2003
Last Update
March 26 2014
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