A Randomized, Open-label, Study of Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Raltegravir 400 mg Twice-Daily in Antiretroviral-Naïve, HIV-1 Infected SubjectsEstudio aleatorizado y abierto de 400/100 mg de lopinavir/ritonavir en comprimidos dos veces al día + coformulación de emtricitabina/tenofovir disoproxil fumarato, 200/300 mg una vez al día, frente a 400/100 mg de lopinavir/ritonavir en comprimidos dos veces al día + raltegravir, 400 mg dos veces al día, en sujetos infectados por el VIH-1 sin tratamiento antirretroviral previo.

Conditions: Treatment-naïve, HIV-1 infected subjectsSujetos infectados por el VIH-1 sin tratamiento antirretroviral previo.
MedDRA version: 9.1Level: LLTClassification code 10020162Term: HIV infection CDC Group I

Registration Number: EUCTR2008-000881-22-ES

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. At least 18 years of age.
2. Naïve to antiretroviral treatment (< 7 days of any antiretroviral treatment therapy
> 30 days prior to study drug administration).
3. No prior treatment with an HIV-1 integrase inhibitor.
4. If the subject has been treated for an active AIDS-defining opportunistic infection
(as denoted by * in Appendix D) within 45 days of planned study drug initiation,
but is clinically stable and on stable maintenance therapy, the subject may be
eligible for participation in the study, only after the investigator contacts the
Abbott Medical Monitor to discuss the issue.
5. Does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. For complete information, refer to the most current product label for locally
approved prescribing information for lopinavir/ritonavir (Kaletra®), co-formulated
emtricitabine/tenofovir disoproxil fumarate (Truvada®), and raltegravir
(Isentress™).
6. Will notify the principal investigator of any drugs taken during the study,
including over-the-counter medicines, vitamins, minerals, or herbal remedies.
7. Not breast-feeding.
8. 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.
9. If female, subject must be either postmenopausal for at least one year, surgically
sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she
must use a non-hormonal method of birth control that is acceptable to both the
subject and investigator, and is consistent with the locally approved prescribing
information for lopinavir/ritonavir.
? All female subjects must have a urine pregnancy test performed at the
Screening Visit and on Day -1/Baseline, and results of both tests must be
negative.
10. Vital signs, physical examination and laboratory results do not exhibit evidence of
acute illness.
11. Plasma HIV-1 RNA level of greater than or equal to 1,000 copies/mL at Screening
and in the investigator's opinion requires antiretroviral therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of an allergic reaction or significant sensitivity to lopinavir/ritonavir,
emtricitabine/tenofovir disoproxil fumarate, or raltegravir.
2. Resistance to lopinavir/ritonavir, tenofovir or emtricitabine based on the HIV-1
drug resistance genotypic test results at the Screening Visit.
3. Ongoing history of recreational drug or alcohol use, or a psychiatric illness that
could preclude adherence with the protocol.
4. Significant medical history of concomitant illness or disease that would adversely
affect his/her participating in this study.
5. Any investigational drug or investigational vaccine received within 30 days prior
to study drug administration.
6. The investigator considers the subject to be an unsuitable candidate for the study.
7. Any of the following abnormal screening results:
? Hemoglobin = 8.0 g/dL
? Absolute neutrophil count = 750 cells/µL
? Platelet count = 50,000 per mL
? ALT (SGPT) or AST (SGOT) = 3.0 × Upper Limit of Normal (ULN)
? Calculated creatinine clearance < 50 mL/min
? Hepatitis B surface antigen HBsAg is positive

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ? To compare the safety and tolerability of lopinavir-ritonavir<br>(LPV/r) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) with a<br>nucleoside-sparing regimen consisting of lopinavir/ritonavir + raltegravir<br>(RLT).<br>? To compare the antiviral efficacy of LPV/r +FTC/TDF and LPV/r+RLT after<br>48 weeks of treatment.;Secondary Objective: ? To compare antiviral efficacy of LPV/r +FTC/TDF and LPV/r+RLT at<br>96 weeks of treatment.<br>? To compare viral decay rates between LPV/r +FTC/TDF and LPV/r+RLT.<br>? To characterize the development of resistance in the two treatment groups.<br>? To compare the population pharmacokinetics of lopinavir and ritonavir<br>between the LPV/r +FTC/TDF and LPV/r+RLT regimens.<br>? To compare the effect of LPV/r +FTC/TDF and LPV/r+RLT on metabolic and<br>somatic parameters.<br>? To compare the effect of LPV/r +FTC/TDF and LPV/r+RLT on patient<br>reported outcomes.;Primary end point(s): The proportion of subjects with HIV-1 RNA < 50 copies/mL at 48 weeks

Secondary Outcome Measures

Name	Time	Method

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