Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir (MK-0518); Placebo
Intervention description: 400 mg tablet taken orally twice daily; 400 mg placebo tablet taken orally twice daily
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against
      HIV-1 strains including those resistant to currently available antiretroviral drugs. The
      purpose of this study is to assess the effectiveness of raltegravir in further reducing viral
      load in HIV infected patients that have already achieved viral suppression below the level of
      detection of standard viral load assays when added to antiretroviral therapy (ART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 Infection

          -  ART for at least 12 months prior to study entry that includes at least two NRTIs and
             either an NNRTI or a ritonavir-boosted PI

          -  No change in ART regimen for at least 3 months prior to study entry

          -  CD4 count of 200 or more at screening

          -  Viral load below the limit of quantification of an ultrasensitive assay for at least 6
             months prior to study entry

          -  Viral load less than 50 copies/ml using Roche Amplicor HIV-1 RNA Ultrasensitive assay
             within 60 days of study entry

          -  All viral load assays obtained within 6 months prior to study entry lower than limits
             of quantification on all tests

          -  Pre-ART viral load level greater than 100,000 copies/ml

          -  Detectable viral load of 1 copy or more on the screening SCA

          -  Available pre-study entry plasma sample for SCA viral load determination

          -  Absolute neutrophil count of 750/mm3 or more

          -  Hemoglobin of 9 g/dL or more for female subjects and 10 g/dL or more for male subjects

          -  Platelet count of 50,000/mm3 or more

          -  Calculated creatinine clearance of 30 ml/min or more

          -  AST, ALT, and alkaline phosphate less than or equal to 5 x ULN

          -  Total bilirubin less than or equal to 2.5 x ULN. If subject is taking indinavir or
             atazanavir at screening, total bilirubin must be less than or equal to 5 x ULN.

          -  Negative serum or urine pregnancy test within 48 hours prior to study entry for
             females with reproductive potential

          -  Willing to use acceptable means of contraception

        Exclusion Criteria:

          -  Previous documented virologic failure on an antiretroviral regimen

          -  Unstable clinical condition that would preclude the subject from undergoing study
             procedures

          -  Use of immunosuppressive medications within 60 days prior to study entry. Participants
             using inhaled or nasal steroids are not excluded.

          -  Opportunistic infection within 60 days prior to study entry

          -  Allergy or sensitivity to components of study drug

          -  Active drug or alcohol abuse

          -  Serious illness requiring systemic treatment within 60 days prior to study entry

          -  Receipt of non-HIV vaccination within 30 days prior to study entry

          -  Receipt of any HIV vaccines

          -  Plan to change background ART within 24 weeks after study entry

          -  Pregnant or breastfeeding