Status:
COMPLETED
"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects
Lead Sponsor:
Arribas, Jose R., M.D.
Collaborating Sponsors:
Pulido, Federico, M.D.
Abbott
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokineti...
Detailed Description
Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides Secondary Study...
Eligibility Criteria
Inclusion
- HIV patients \> 18 years old who provide signed and dated Informed consent.
- HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.
- Plasma HIV RNA \< 50 cop/ml for six months
Exclusion
- HIV patients who have stopped a protease inhibitor due to virological failure.
- HIV patients with hepatic or renal insufficiency.
- HIV patients with positive serum HBVAg
- HIV patients who require treatment with a lopinavir/r contraindicated medication.
- HIV pregnant or breastfeeding women.
- Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00114933
Start Date
January 1 2005
End Date
May 1 2007
Last Update
March 21 2008
Active Locations (28)
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1
Hospital General de Alicante
Alicante, Alicante, Spain, 03010
2
Hospital General de Elche
Elche, Alicante, Spain, 03202
3
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
4
Hospital Sant Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025