Kaletra-isentress Treatment Evaluation
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Kaletra + Isentress; Pre-study antiretroviral regimen
Intervention description: Kaletra 400/100 mg + Isentress 400 mg BID; Standard doses of pre-study antiretroviral regimen
Intervention MeSH terms: Ritonavir; Lopinavir; Raltegravir Potassium; Anti-Retroviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HAART; lopinavir/ritonavir; raltegravir; HIV/AIDS patients on HAART; Treatment Experienced

Summary:

      This study will examine the effectiveness and safety of raltegravir (isentress) when used
      together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is
      a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong
      effects against the HIV virus. Isentress has been shown in other studies to be safe and well
      tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a
      HIV regimen that does not include the more toxic drugs of the nucleoside reverse
      transcriptase inhibitor class.

      Eligible volunteers will undergo the following as part of the study procedure:

        1. Sign the study consent form and the HIPAA Authorization Form.

        2. Two-third of subjects, the intervention group (selected by random chance) will have
           their HIV drug treatment changed to kaletra + isentress.

        3. The other one-third will continue their usual HIV medications (this will be the control
           group).

        4. Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During
           these visits, medical information will be collected, and blood tests will be performed.

        5. Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.

      Information collected will be used to assess the effectiveness of this treatment in keeping
      the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected
      patients, and the blood levels of these two drugs when given together.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be
             1st PI-containing HAART).

          -  They must have been on and tolerating current HAART regimen for > 6-months.

          -  Plasma HIV-1 viral load < 50 copies/ml at study entry.

          -  Men and women age > 18 years (sex is defined as sex at birth).

          -  Laboratory values obtained within 30 days prior to study entry:

               -  Hemoglobin > 9.4 g/dl

               -  Creatinine < 2 mg/dl

               -  AST (SGOT) < 2 x ULN

               -  ALT (SGPT) < 2 x ULN

          -  Ability and willingness of subject or legal guardian/representative to give written
             informed consent.

          -  No CD4 T-cell counts requirement

        Exclusion Criteria:

          -  Subjects with a history of previous intolerance to or virological failure to LPV/r

          -  Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma
             concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase
             iso-enzymes).

          -  A known history of noncompliance with medications or a known history of noncompliance
             with scheduled physician and clinic visits.

          -  Investigational ARV drug.

          -  Pregnancy/Breast feeding.

          -  HBV-coinfected patients receiving nucleoside analogue for both HIV and HBV
             suppression.

          -  Active drug or alcohol use or dependence which, in the Investigator's opinion, may
             interfere with adherence to study requirements or endanger subject's health while on
             the study.

          -  Serious illness requiring systemic treatment and/or hospitalization within 30 days
             prior to the screening visit.