Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients (NCT00082628) | Clinical Trial Compass
CompletedPhase 3
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
United States326 participantsStarted 2004-05-28
Plain-language summary
The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have written laboratory documentation of an HIV infection by one of the following methods:
✓. Have evidence of excess abdominal adipose deposition when measured by the anthropometric methodology, using the following cut off values:
✓. Are taking antiretroviral medication(s) which is (are) approved or is (are) available under a Treatment IND. The regimen must have remained stable for 30 days prior to study entry. Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
✓. Have parameter values less than the following limits (using results from the central laboratory):
✓. Weight \>= 36 kg (79.3 lb)
✓. Be between 18 and 60 years of age (inclusive) unless local law dictates different limits.
✓. Sufficiently literate in English to be able to comprehend and complete the Quality of Life Questionnaire.
✓. Willing and able to comply with the protocol for the duration of the study.
Exclusion criteria
✕. Have an active AIDS-defining opportunistic complication (OC) as defined by the CDC or have had an untreated or suspected serious systemic infection, or have had a persistent fever \>= 101°F (38.3°C) during the 30 days prior to study entry.
✕. Any active or past history of malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy). Such exceptions must be confirmed in writing by the Serono Study Director.
What they're measuring
1
Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12
✕. Have a CNS mass or active CNS process associated with neurological findings.
✕. Have unstable or untreated hypertension, defined as \>= 140/90 mm Hg at the time of the Screening Visit, and/or have initiated or changed antihypertensive therapy in the 30 days prior to Study Day 1.
✕. Have an acute critical illness treated in an intensive care unit, e.g., due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
✕. Have a recent history of sleep apnea or intermittent upper respiratory obstruction.
✕. Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
✕. Are unable to comply with the Concomitant Therapy restrictions including: