| Eligibility |
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.
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