Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Saint Michael's Medical Center
ClinicalTrials.gov Identifier:
NCT00752037
First received: September 12, 2008
Last updated: July 19, 2011
Last verified: September 2008
  Purpose

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
HIV Infections
Drug: lopinavir/ritonavir and raltegravir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Lopinavir/Ritonavir in Combination With Raltegravir in HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by Saint Michael's Medical Center:

Primary Outcome Measures:
  • The primary objective of this trial is to evaluate the percentage of patients with HIV-1 RNA below 50 copies at week 48 receiving lopinavir/ritonavir in combination with raltegravir [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of lopinavir/ritonavir in combination with raltegravir in maintaining virological suppression [ Time Frame: weeks 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
  • To evaluate the change from baseline in plasma HIV-1 RNA at weeks 12, 24, 36, and 48 [ Time Frame: weeks 12, 24, 36, and 48 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
open label single arm
Drug: lopinavir/ritonavir and raltegravir
lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.
Other Name: Kaletra, Isentress

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
  2. Males and non-pregnant females > 18 years of age. (Children are being excluded as they are immunologically different than adults)
  3. HIV-1 RNA > 1000 copies/ml for both patient naive and experienced to antiretroviral therapy in order for phenotypic susceptibility to be performed. There in no inclusion criteria for CD4 count.
  4. Treatment experienced patients , defined as having taken medications from two of the following three classes of antiretrovirals: NRTI, NNRTI, or PI must have phenotypic susceptability to lopinavir/ritonavir as resulted by Phenosense GT
  5. Laboratory tests ( Cbc w/diff, comprehensive metabolic panel) within pre-specified limits
  6. Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
  7. Available for at least 52 weeks of follow up
  8. If female and of child bearing potential must consent to remain abstinent throughout the study period and for 30 days after the last dose of study medications.( this is standard language)

Exclusion Criteria:

  1. Pregnant or breast-feeding woman (pregnant women are being excluded as drug kinetics are different in pregnancy and the dynamics of immune reconstitution are unknown in this group)
  2. Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or isolated cutaneous Kaposi's Sarcoma that is not being treated; those with prior cancer diagnosis, such as lymphomas must have been disease-free for at least 5 years
  3. Absolute neutrophil count < 500, platelet count < 50,000, hemoglobin < 8 gm/dL
  4. Evidence of end-organ disease, defined as follows: renal (calculated creatinine clearance of less than 50 mL/min); liver (liver-associated enzymes > 3 times the upper limits of normal)
  5. Grade 3 (ACTG Grading Scale) or higher cholesterol or triglyceride elevations
  6. Acute, serious infection requiring prescription drug therapy within 30 days prior to study entry
  7. In the opinion of the investigator, there is evidence of an active ongoing opportunistic infection
  8. Must not currently be undergoing treatment for an opportunistic infection.
  9. Use of immune stimulation agents known to impact CD4 cell count in the peripheral circulation, to include IL2, interferon, G-CSF, GM-CSF, etc.
  10. Use of immune suppressant drugs, with the exception of < 10 mg/day of prednisone .
  11. Unwillingness to remain abstinent for duration of study
  12. Experimental vaccines, to include HIV vaccines.
  13. Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.
  14. Patients on 2 NRTIs with an NNRTI and a PI combination will not be allowed in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752037

Locations
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Saint Michael's Medical Center
Abbott
Investigators
Principal Investigator: Jihad Slim, MD Saint Michael's Medical Center
  More Information

No publications provided

Responsible Party: JIhad Slim,Md, Saint Michael's Medical Center
ClinicalTrials.gov Identifier: NCT00752037     History of Changes
Other Study ID Numbers: INV 08/08
Study First Received: September 12, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Michael's Medical Center:
HIV
Protease Inhibitor
Integrase Inhibitor
Treatment Experienced
Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Integrase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014