Inclusion Criteria:
Inclusion Criteria
- Subject is at least 18 years of age.
- Subject is confirmed HIV positive and in the investigator's opinion requires
antiretroviral (ARV) therapy.
- Subject is naïve to HIV ARV therapy or has received < 7 days total of any HIV ARV
therapy > 30 days prior to study drug administration.
- Subject's HIV RNA is >= 1000 copies/mL at screening.
- If sexually active, subject agrees to use safe sex practices to reduce risk of HIV
transmission (e.g., male or female condom, vaginal dam, etc.).
- If female, the results of a urine pregnancy test performed at screening and on Day
1/Baseline are both negative.
- If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy), or is of childbearing potential and practicing one of
the following methods of birth control:
- A. Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
- B. A vasectomized partner.
- C. Total abstinence from sexual intercourse.
- Subject is not breastfeeding.
- Subject's vital signs, physical examination, and laboratory results do not exhibit
evidence of acute illness.
- Subject has a Karnofsky score greater than or equal to 70.
- Subject agrees not to take any drugs during the study, including over-the-counter
medicines, vitamins, mineral supplements, herbal preparations, alcohol, or
recreational drugs without the knowledge and permission of the investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection
within 30 days of initiating study drug.
- Subject has voluntarily signed and dated an informed consent form, approved by an
Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature
of the study has been explained and the subject has had the opportunity to ask
questions. The informed consent must be signed before any study-specific procedures
are performed.
Exclusion Criteria
- A subject will be excluded from the study if he/she meets any of the following
criteria:
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir,
ritonavir, lamivudine, zidovudine, efavirenz, or to any inert materials contained in
the study drug formulations.
- Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic,
endocrinologic, metabolic, or hepatic disease that would, in the opinion of the
investigator, adversely affect his/her participation in this study.
- Subject is currently taking any drug (medicinal or herbal) that is contraindicated
and/or not to be co-administered with any of the three study drugs as defined in the
current locally approved prescribing information.
- Subject has a history of drug and/or alcohol abuse or psychiatric illness that in the
investigator's opinion could preclude compliance with the protocol.
- Subject is receiving immunomodulatory agents, colony stimulating factor, bone marrow
stimulants (e.g., erythropoietin [Procrit®, Epogen®] or filgrastim [Neupogen®]),
ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents.
- The TRUGENE HIV-1 resistance report indicates resistance or possible resistance to the
study reverse transcriptase inhibitor(s) [RTI(s)] (efavirenz, lamivudine or
zidovudine) OR the presence of any mutation in the protease gene leading to an amino
acid substitution at the following loci: 8, 30, 32, 46, 47, 48, 50, 54, 82, 84, or 90
OR four or more mutations at the following loci: 10, 20, 24, 36, 53, 63, or 71.
- Screening laboratory analyses show any of the following abnormal laboratory results:
Presence of Hepatitis B surface antigen (HBsAg); Hemoglobin <= 9.5 g/dL; Absolute
neutrophil count <= 1000 cells/mL; Platelet count <= 50,000 per mL; ALT (SGPT) or AST
(SGOT) >= 3.0 x Upper Limit of Normal (ULN); Fasting Triglycerides > 750 mg/dL;
Fasting Cholesterol > 300 mg/dL; Creatinine >= 1.5 x Upper Limit of Normal (ULN);
Fasting serum glucose > 126 mg/dL
- Subject is taking a prescribed lipid lowering medication such as HMG-CoA Reductase
Inhibitors (statin) or fibrate medications.
- Subject has a history of diabetes mellitus.
- Subject has received any investigational drug or vaccine within 30 days prior to study
drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable
candidate to participate in the study.
