Status:
COMPLETED
Kaletra-isentress Treatment Evaluation
Lead Sponsor:
Emory University
Collaborating Sponsors:
Abbott
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food ...
Detailed Description
RATIONALE: Virologic failure and adverse effects associated with current highly active antiretroviral therapy (HAART) warrant continuing search for novel combination therapeutic options. Raltegravir's...
Eligibility Criteria
Inclusion
- HIV-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be 1st PI-containing HAART).
- They must have been on and tolerating current HAART regimen for \> 6-months.
- Plasma HIV-1 viral load \< 50 copies/ml at study entry.
- Men and women age \> 18 years (sex is defined as sex at birth).
- Laboratory values obtained within 30 days prior to study entry:
- Hemoglobin \> 9.4 g/dl
- Creatinine \< 2 mg/dl
- AST (SGOT) \< 2 x ULN
- ALT (SGPT) \< 2 x ULN
- Ability and willingness of subject or legal guardian/representative to give written informed consent.
- No CD4 T-cell counts requirement
Exclusion
- Subjects with a history of previous intolerance to or virological failure to LPV/r
- Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase iso-enzymes).
- A known history of noncompliance with medications or a known history of noncompliance with scheduled physician and clinic visits.
- Investigational ARV drug.
- Pregnancy/Breast feeding.
- HBV-coinfected patients receiving nucleoside analogue for both HIV and HBV suppression.
- Active drug or alcohol use or dependence which, in the Investigator's opinion, may interfere with adherence to study requirements or endanger subject's health while on the study.
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the screening visit.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00700115
Start Date
June 1 2008
End Date
January 1 2011
Last Update
December 12 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Grady Infectious Diseases Program (Ponce Clinic)
Atlanta, Georgia, United States, 30308