Clinical trial NCT00485264 (phase 1/phase 2, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: raltegravir poloxamer film coated tablet, raltegravir chewable tablet, raltegravir oral granules for suspension (20 mg/ml), raltegravir poloxamer film coated tablet
SMILES: CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1
Eligibility criteria:

        Inclusion Criteria for All Participants:

          -  Documentation of HIV-1 infection, defined as positive results from two samples
             collected at different time points. More information on this criterion can be found in
             the protocol.

          -  For participants in Cohorts I, IIA, IIB, and III: On unchanged therapeutic regimen for
             at least 12 weeks, or treatment experienced (not including therapy to interrupt
             maternal-to-child-transmission (MTCT)) but on no treatment for 4 or more weeks prior
             to study entry. More information on this criterion can be found in the protocol.

          -  Participants in Cohorts IV must have received therapy to either interrupt MTCT and/or
             to treat HIV infection and participants in Cohort V must have received therapy to
             interrupt MTCT but have not received other anti-HIV therapies.

          -  HIV RNA (ribonucleic acid) of 1,000 copies/mL or greater at screening

          -  Demonstrated ability or willingness to take assigned raltegravir preparation

          -  Parent or legal guardian or participant able and willing to provide signed informed
             consent when applicable

          -  Female participants who are sexually active and potentially able to become pregnant
             must use two methods of birth control while on study and for 3 months after stopping
             study drug. More information on this criterion can be found in the protocol. Male
             participants must not participate in sperm donation programs. Male participants
             engaging in sexual activity that could lead to pregnancy must use a condom.

          -  Willing to be re-registered within same cohort if a dose change is recommended

        Exclusion Criteria for All Participants:

          -  Known Grade 3 or higher of any of the following laboratory tests within 30 days prior
             to study entry: neutrophil count, hemoglobin, platelets, aspartate aminotransferase
             (AST), alanine aminotransferase (ALT), lipase, serum creatinine

          -  Clinical evidence of pancreatitis

          -  Treatment for active tuberculosis (TB) infection or disease.

          -  History of lactic acidosis in 3 months prior to study entry. More information on this
             criterion can be found in the protocol.

          -  Diagnosis of new Centers for Disease Control Stage C criteria or opportunistic or
             bacterial infection diagnosed within 30 days prior to study screening and not
             considered clinically stable

          -  Prior treatment with another experimental HIV integrase inhibitor

          -  Immunosuppressive therapy within 30 days prior to beginning raltegravir study
             treatment. Participants taking short courses of corticosteroids are not excluded.

          -  Current or anticipated use of any disallowed medications, listed in the protocol.

          -  Any history of malignancy

          -  Participants who are unlikely to adhere to the study procedures or keep appointments

          -  Participants who are planning to relocate during study

          -  Any clinically significant diseases (other than HIV) or findings during the screening
             medical history or physical examination that, in the opinion of the investigator,
             would compromise the outcome of the study

          -  Current or past participation in an investigational study with a compound or device
             that is not commercially available within 30 days of signing informed consent

          -  Participants who are pregnant or breastfeeding. Infants who are receiving breastmilk
             are allowed to enroll.

          -  For participants in Cohorts IV and V, participant's caregiver is unable to access
             clean water supply (as defined by local standards) to re-suspend raltegravir oral
             granules

        Exclusion Criteria for Stage I Participants:

          -  Stage I mini cohort (initial 4 participants) only: current or anticipated use of
             antiretroviral regimen that includes atazanavir, tenofovir, or tipranavir during Stage
             I. Any other commercially available antiretroviral drugs are acceptable.

          -  Stage I participants enrolling after initial 4 participants: use of atazanavir,
             tenofovir, or tipranavir prior to the intensive PK testing. More information on this
             criterion can be found in the protocol.

        Exclusion Criteria for Stage II Participants Taking Atazanavir as Part of Their Background
        Regimen:

          -  Total bilirubin of Grade 4 or higher within 30 days of study entry

          -  Total bilirubin value lower than Grade 4 but direct bilirubin or concurrent
             transaminase greater than 1.5 times the upper limit of normal and participant is
             symptomatic, within 30 days prior to study entry