Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: GW433908; ritonavir
Intervention description: Fosamprenavir suspension bid; Ritonavir solution bid
Intervention MeSH terms: Ritonavir; Fosamprenavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 4 Weeks
Maximum age: 2 Years
Healthy volunteers: No
Keywords: pediatrics; ritonavir; amprenavir; AGENERASE; HIV; Lexiva; protease inhibitors; HIV Infection; fosamprenavir

Summary:

      This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral
      activity of an investigational regimen including FDA approved HIV drugs in HIV-infected
      pediatric subjects, ages 4 weeks to < 2 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 4 weeks to <2 years of age. Cohort 1 (6 months - <2 years): Subjects
             must be <2 years of age at the Week 2 visit therefore the maximum age at screening is
             22 months.

        Cohort 2 (4 weeks - <6 months): Subjects must be <6 months of age at the Week 2 visit,
        therefore the maximum age at screening is 4 months for entry into this cohort.

          -  Parent or legal guardian is willing and able to provide written informed consent for
             the subject to participate in the trial.

          -  Screening plasma HIV-1 RNA level >=400copies/mL.

          -  Subjects who, in the investigator's opinion, and following viral resistance testing if
             conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor
             (NRTI) backbone regimen consisting of 2 NRTIs.

          -  Subjects must meet one of the following criteria:

        Therapy-naïve or PI-naïve subjects (defined as having received less than one week of any
        PI).

        PI-experienced subjects defined as having prior experience with no more than three PIs.
        Prior RTV-boosted PI therapy will be considered as only one PI as long as the RTV dose was
        lower than that recommended for use of RTV as an antiretroviral agent.

        Exclusion Criteria:

          -  Prior history of having received APV.

          -  Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to
             study drug administration (single or multiple dose) or anticipated need for concurrent
             NNRTI therapy during the study period.

          -  PI therapy within 5 days prior to study drug administration (applicable only for
             subjects undergoing single dose visits)

          -  Subjects and/or parents/legal guardians who, in the investigator's opinion, are not
             able to comply with the requirements of the study.

          -  Subject is in the initial acute phase of a Centers for Disease Control and Prevention
             (CDC) Clinical Category C event or infection (per 1994 classification) at Baseline.
             Subject may be enrolled provided they are receiving treatment for the infections, such
             treatment not being contraindicated with FPV, and subjects are clinically improving at
             the Baseline visit.

          -  Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might
             interfere with drug absorption or render the subject unable to take oral medication.

          -  Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia,
             diabetes, cardiac dysfunction, hepatitis, or clinically relevant pancreatitis) which,
             in the opinion of the investigator, might compromise the safety of the subject.

          -  Any acute laboratory abnormality at screen which, in the opinion of the investigator,
             should preclude the subject's participation in the study of an investigational
             compound. If subjects are found to have an acute Grade 4 laboratory abnormality at
             screening, this test may be repeated once within the screening window. Any verified
             Grade 4 laboratory abnormality would exclude a subject from study participation.

          -  Grade 3 or higher (>10x ULN) serum aminotransferase levels (alanine aminotransferase,
             ALT and/or aspartate aminotransferase, AST) within 28 days prior to study drug
             administration and / or clinically relevant hepatitis within the previous 6 months.

          -  Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days
             of study drug administration or an anticipated need for such treatment within the
             study period.

          -  Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins,
             interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or
             foscarnet) within 28 days of study drug administration.

          -  Treatment with any of the following medications within 28 days prior to receiving
             study medication or the anticipated need during the study:

        Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam,
        dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam,
        lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone,
        propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been
        excluded for safety reasons).

        Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these
        drugs have been excluded because they have the potential to decrease plasma protease
        inhibitor concentrations).

          -  Treatment with other investigational drugs/therapies within 28 days prior to receiving
             study medication (note: treatments available through a Treatment IND or other
             expanded-access mechanism will be evaluated on a case-by-case basis in consultation
             with the sponsor).

          -  History of drug or other allergy which, in the opinion of the investigator,
             contraindicates participation in the trial or known hypersensitivity to any study
             medications (e.g. documented hypersensitivity to a nucleoside analogue).