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

NCT00752037 | Completed Phase 4

• 1 other identifier: INV 08/08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

HIV; Protease Inhibitor; Integrase Inhibitor; Treatment Experienced; Naive

Outcome Measures

Primary Outcomes (1)

• 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

  week 48

Secondary Outcomes (2)

• To evaluate the effect of lopinavir/ritonavir in combination with raltegravir in maintaining virological suppression

  weeks 12, 24, 36, and 48

• To evaluate the change from baseline in plasma HIV-1 RNA at weeks 12, 24, 36, and 48

  weeks 12, 24, 36, and 48

Study Arms (1)

1

OTHER

open label single arm

Drug: lopinavir/ritonavir and raltegravir

Interventions

lopinavir/ritonavir and raltegravir DRUG

lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.

Also known as: Kaletra, Isentress

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males and non-pregnant females \> 18 years of age. (Children are being excluded as they are immunologically different than adults)
• 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
• Laboratory tests ( Cbc w/diff, comprehensive metabolic panel) within pre-specified limits
• Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
• Available for at least 52 weeks of follow up
• 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)

You may not qualify if:

• 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)
• 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
• Absolute neutrophil count \< 500, platelet count \< 50,000, hemoglobin \< 8 gm/dL
• 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)
• Grade 3 (ACTG Grading Scale) or higher cholesterol or triglyceride elevations
• Acute, serious infection requiring prescription drug therapy within 30 days prior to study entry
• In the opinion of the investigator, there is evidence of an active ongoing opportunistic infection
• Must not currently be undergoing treatment for an opportunistic infection.
• Use of immune stimulation agents known to impact CD4 cell count in the peripheral circulation, to include IL2, interferon, G-CSF, GM-CSF, etc.
• Use of immune suppressant drugs, with the exception of \< 10 mg/day of prednisone .
• Unwillingness to remain abstinent for duration of study
• Experimental vaccines, to include HIV vaccines.
• Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.
• Patients on 2 NRTIs with an NNRTI and a PI combination will not be allowed in the study.

Sponsors & Collaborators

• Saint Michael's Medical Center: lead
• Abbott: collaborator

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir; Ritonavir; Raltegravir Potassium; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Pyrrolidinones; Pyrrolidines

Study Officials

• Jihad Slim, MD

  Saint Michael's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 15, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 20, 2011

Record last verified: 2008-09

Locations

US (1)