Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: emtricitabine/tenofovir; abacavir/lamivudine
Intervention description: The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.; The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.
Intervention MeSH terms: Tenofovir; Lamivudine; Emtricitabine; Abacavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 688.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HEAT; Antiretroviral-naive; HIV; EPZICOM; TRUVADA; KALETRA; once-daily

Summary:

      This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine)
      and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used
      in combination with KALETRA (lopinavir/ritonavir) over 96 weeks
    

Eligibility criteria:

        Inclusion criteria:

          -  Males as females at least 18 years old. (A female is eligible to enter and participate
             in this study if she is of: non child-bearing potential, child bearing potential with
             a negative pregnancy test and agrees to approved contraception methods, or agreement
             for complete abstinence.)

          -  Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any
             NRTI and no prior therapy with either a PI or NNRTI).

          -  Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL at screening.

          -  Subject is willing and able to understand and provide written informed consent prior
             to participation in this study.

        Exclusion criteria:

          -  Subject has an active or acute CDC Clinical Category C event (exclusive of cutaneous
             Kaposi's sarcoma) at screening. Treatment for the acute event must have been completed
             at least 30 days prior to screening.

          -  Subject is enrolled in one or more investigational drug protocols, which may impact
             HIV-1 RNA suppression.

          -  Subject is, in the opinion of the investigator, unable to complete the 96-week dosing
             period and protocol evaluations and assessments.

          -  Subject is either pregnant or breastfeeding.

          -  Subject has an ongoing clinically relevant pancreatitis or clinically relevant
             hepatitis at screening.

          -  Subject suffers from a serious medical condition, such as cirrhosis, diabetes,
             congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the
             opinion of the investigator would compromise the safety of the subject.

          -  Subject has a pre-existing mental, physical, or substance abuse disorder which, in the
             opinion of the investigator, may interfere with the subject's ability to comply with
             the dosing schedule and protocol evaluations and assessments.

          -  Subject has a history of inflammatory bowel disease or malignancy, intestinal
             ischemia, malabsorption, or other gastrointestinal dysfunction which may interfere
             with drug absorption or render the subject unable to take oral medication.

          -  Subject has any acute laboratory abnormality at screening, which, in the opinion of
             the investigator, precludes the subject's participation in the study of an
             investigational compound. Any grade 4 laboratory abnormality will exclude a subject
             from study participation.

          -  Subject has estimated creatinine clearance <50 mL/min via Cockroft-Gault method.

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper
             limit of normal (ULN).

          -  Subject has required treatment with radiation therapy or cytotoxic chemotherapeutic
             agents within 28 days prior to screening, or has an anticipated need for these agents
             within the study period.

          -  Subject requires treatment with immunomodulating agents (such as systemic
             corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to
             Screen, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days
             prior to Screen. Asthmatic subjects using inhaled corticosteroids are eligible for
             enrollment.

          -  Subject requires treatment with foscarnet, hydroxyurea or other agents with documented
             activity against HIV-1 in vitro within 28 days of study administration.

          -  Subjects who require treatment with the prohibited medications within 28 days of
             commencement of investigational product, or an anticipated need during the study.

          -  Subject has a history of allergy to any of the study drugs or any excipients therein