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

NCT ID: NCT00752037

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-06-30

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

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

open label single arm

Group Type: OTHER

lopinavir/ritonavir and raltegravir

Intervention Type: DRUG

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

Interventions

lopinavir/ritonavir and raltegravir

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

Intervention Type: DRUG

Other Intervention Names

Kaletra, Isentress

Eligibility 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)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Saint Michael's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Saint Michael's Medical Center

Principal Investigators

Jihad Slim, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Michael's Medical Center

Locations

Saint Michael's Medical Center

Newark, New Jersey, United States

Countries

United States

Other Identifiers

INV 08/08

Identifier Type: -

Identifier Source: org_study_id