Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

Last updated: February 13, 2012
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Aids And Aids Related Infections

Hiv/aids

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT00711009
M10-336
2008-000881-22
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must provide written, voluntary informed consent to participate in thestudy.

  • Participants must be naive to antiretroviral treatment with HIV RNA greater than orequal to 1,000 copies/mL at screening, and in the investigator's opinion, requireantiretroviral therapy.

  • Participant's vital signs, physical examination, and laboratory results must notexhibit evidence of acute illness.

  • Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug.Participants who are on stable maintenance therapy for an opportunistic infection maybe enrolled after consultation with the Sponsor.

  • Participant does not require and agrees not to take any drugs that are contraindicatedor have significant pharmacokinetic interactions with study drugs during the course ofthe study. Participant agrees not to take any medication during the study, includingover-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, orrecreational drugs without the knowledge and permission of the principal investigator.

  • Female participants must be either postmenopausal for at least one year, surgicallysterile, or must use a non-hormonal method of birth control that is acceptable to boththe participant and investigator. All female participants must have a urine pregnancytest performed at screening visit and on Day minus 1/baseline, and results of bothtests must be negative. Female participants may not be breastfeeding.

  • Participants have received no prior treatment with an HIV-1 integrase inhibitor.

Exclusion

Exclusion Criteria:

  • Participants must not have history of an allergic reaction or significant sensitivityto the study drugs.

  • Participants may not have an ongoing history of substance abuse or psychiatric illnessthat could preclude protocol adherence.

  • Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabinebased on the HIV-1 drug resistance genotypic test results at the screening visit.

  • Participant may not have significant medical history of concomitant illness or diseasethat would adversely affect his/her participating in the study.

  • Participants may not have received any investigational drug or investigational vaccinewithin 30 days prior to study drug administration.

  • Participants may not have any of the following abnormal screening results: Hemoglobin <= 8.0 grams/deciliter, absolute neutrophil count <= 750 cells/microliter, Plateletcount <= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvictransaminase [SGPT]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetictransaminase [SGOT]) >= 3.0 x upper limit of normal (ULN), calculated creatinineclearance < 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.

  • The investigator considers the participant to be an unsuitable candidate for thestudy.

Study Design

Total Participants: 206
Study Start date:
July 01, 2008
Estimated Completion Date:
October 31, 2010

Connect with a study center

  • Site Reference ID/Investigator# 7963

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 7831

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 7959

    Toronto, Ontario M5B 1L6
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 8099

    Montreal, Quebec H2L 5B1
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 7695

    Lyon, 69000
    France

    Site Not Available

  • Site Reference ID/Investigator# 7695

    Lyon Cedex 04, 69317
    France

    Site Not Available

  • Site Reference ID/Investigator# 7960

    Montpellier, 34295
    France

    Site Not Available

  • Site Reference ID/Investigator# 7960

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Site Reference ID/Investigator# 7821

    Paris, 75014
    France

    Site Not Available

  • Site Reference ID/Investigator# 8063

    Paris, 75012
    France

    Site Not Available

  • Site Reference ID/Investigator# 8052

    Genoa, 16132
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 8052

    Genova, 16132
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 7789

    Milan, 20127
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 8051

    Perugia, 06156
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 8050

    Rome, 00184
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 8221

    Wroclaw, 50-220
    Poland

    Site Not Available

  • Site Reference ID/Investigator# 7713

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Site Reference ID/Investigator# 7700

    Ponce, 00717-1563
    Puerto Rico

    Site Not Available

  • Site Reference ID/Investigator# 11102

    Barcelona, 08041
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7689

    Barcelona, 8036
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7697

    Barcelona, 08916
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7692

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7691

    Madrid, 28046
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7693

    Madrid, 28041
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7698

    Madrid, 28006
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 7690

    Seville, 41013
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 8431

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8432

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8394

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8393

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8425

    Orlando, Florida 32803
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8402

    Tampa, Florida 33614
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8396

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8395

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8429

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8424

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8426

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Site Reference ID/Investigator# 11461

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8403

    Dallas, Texas 75246
    United States

    Site Not Available

  • Site Reference ID/Investigator# 8433

    Houston, Texas 77004
    United States

    Site Not Available

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