Status:
COMPLETED
Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
Tufts Medical Center
Merck Sharp & Dohme LLC
Conditions:
HIV
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabete...
Detailed Description
The success of combination antiretroviral therapy heralded a revolution in the management of patients with HIV in the mid-1990s. Increasingly, severe treatment-associated metabolic side effects have b...
Eligibility Criteria
Inclusion
- Age \>18
- Fasting LDL\>130 mg/dL
- Fasting triglycerides \>250 mg/dL
- Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study entry.
- No prior history of any NRTI resistance.
Exclusion
- History of NRTI resistance mutations
- Need for medications that have drug interactions with raltegravir: dilantin, phenobarbitol and rifampin
- Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
- Breast-feeding or pregnancy.
- Use of immunosuppressive medications within 60 days prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00887653
Start Date
May 1 2009
End Date
April 1 2014
Last Update
October 10 2014
Active Locations (2)
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1
Tufts University
Boston, Massachusetts, United States, 02111
2
Miriam Hospital Immunology Clinic
Providence, Rhode Island, United States, 02906