Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive (+) Patients With Viral Suppression KIMBO Study

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the hypothesis that the use of Lopinavir/ritonavir will be associated with improved CD4 immune reconstitution in volunteers who fail to demonstrate a significant CD4 cell increase (while on their first antiretroviral treatment regimen) despite sustained viral suppression by a non-Lopinavir/ritonavir-containing regimen

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion criteria

1. Human Immunodeficiency Virus type-1 (HIV-1)infection, as documented by any licensed enzyme-linked immunosorbent assay 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.

3. Currently on a stable antiretroviral regimen for at least 6 months prior to enrollment. This stable regimen must be their first treatment regimen, however, prior changes could have been made for toxicity or intolerability, or where providers were using an "induction /maintenance"type of treatment strategy.

4. HIV-1 RNA < 400 copies/ml (or <500 copies/ml for the bDNA test or <40 copies/ml for the nucleic acid sequence based amplification [NASBA test]) for at least 24 months; and an HIV-1 RNA < 50 copies/ml at screening; interim, non-consecutive viral load blips of < 1,000 copies/mL will be allowed

5. Or, HIV-1 RNA < 400 copies/ml (or <500 copies/ml for the bDNA test or <40 copies/ml for the NASBA test)for minimum of 12 months, during which the HIV-1 RNA was < 50 copies/ml (or <500 copies/ml for the bDNA test or <40 copies/ml for the NASBA test) for 6 months prior to screening, and < 50 copies/mL at screen

6. At a minimum of twelve months post-initiation of antiretroviral therapy, CD4 count remains < 200 cells/mm3, or if baseline CD4 count was between 200-300, and there is an increase of < 50 cells/mm3 over a 12 month period.

7. Laboratory tests within pre-specified limits

8. Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.

9. Available for at least 48 weeks of follow up.

10. If female and of child bearing potential must consent to using at least two forms of contraception

11. Participant must have a Primary Care Provider in order to be enrolled in this study.

Exclusion criteria

1. Pregnant or breast-feeding woman

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 Interleukin 2 (IL2), interferon,Granulocyte Colony-Stimulating Factor(G-CSF),Granulocyte Macrophage Colony-stimulating Factor (GM-CSF), etc.

10. Use of immune suppressive drugs.

11. Subject is currently taking any of the following drugs: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, St. John's Wort, doxorubicin, ribavirin, coumadin.

12. Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic (including diabetes mellitus), metabolic, or hepatic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.

13. Unable or unwillingness to discontinue use of specific medications implicated in drug interactions while on Lopinavir/ritonavir

14. Known hypersensitivity, allergic reactions, or intolerance to Lopinavir/ritonavir or to ritonavir in the past

15. Have previously received Lopinavir/ritonavir for more than 3 months in the past

16. Active substance or alcohol abuse, in the opinion of the principal investigator would interfere with protocol adherence

17. Unwillingness to use effective barrier contraception.

18. Experimental vaccines, to include HIV vaccines.

19. Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.

20. Patients on 2 nucleoside reverse transcriptase inhibitors(NRTIs) with an Non-nucleoside-reverse transcriptase inhibitor(NNRTI) and a protease inhibitor (PI) combination will not be allowed in the study.