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Sponsors and Collaborators: |
Saint Michael's Medical Center Abbott |
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Information provided by: | Saint Michael's Medical Center |
ClinicalTrials.gov Identifier: | NCT00752037 |
A single center, open label, 48-week study of lopinavir/ritonavir in combination with raltegravir. 30 patients, both naïve and experienced, will be enrolled. 15 treatment naïve patients and 15 treatment experienced patients enrolled
Condition | Intervention | Phase |
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HIV Infections |
Drug: lopinavir/ritonavir and raltegravir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Safety and Efficacy of Lopinavir/Ritonavir in Combination With Raltegravir in HIV-Infected Patients |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
open label single arm
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Drug: lopinavir/ritonavir and raltegravir
lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.
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This is an open-labeled, non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria. This study will assess the impact of lopinavir/ritonavir in combination with raltegravir on HIV-1
Patients will be evaluated frequently over the 52 weeks of the protocol. Patients will be seen at screening, baseline, week 4, 12, 24, 36, 48, and 52, to include physical examination, assessment for the development of AIDS-defining conditions, hematology, chemistry, lipid profile, CD4, CD8 cell counts, plasma HIV-1 RNA ultrasensitive, and assessment of adverse events. If HIV-1 RNA becomes detectable, this will be repeated for confirmation with 2 weeks. HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of > 1,000 copies/mL.
An interim analysis will be performed when all patients have reached the week 24 visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James P Fallon, BA | 9738772663 | jimf@smmcnj.org |
United States, New Jersey | |
Saint Michael's Medical Center | Recruiting |
Newark, New Jersey, United States, 07102 |
Principal Investigator: | Jihad Slim, MD | Saint Michael's Medical Center |
Responsible Party: | Saint Michael's Medical Center ( JIhad Slim,Md ) |
Study ID Numbers: | INV 08/08 |
Study First Received: | September 12, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00752037 |
Health Authority: | United States: Institutional Review Board |
HIV Protease Inhibitor Integrase Inhibitor Treatment Experienced Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |