A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Condition: Human Immunodeficiency Virus Infections
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Efavirenz 600mg; Boosted Lexiva
Intervention description: QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
The intervention may be switched for the following reasons:
To resolve a Grade 3 or 4 Adverse Event
The subject experienced a virologic failure (as defined in section 3.6.2)
The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide); Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
The intervention may be switched for the following reasons:
To resolve a Grade 3 or 4 Adverse Event
The subject experienced a virologic failure (as defined in section 3.6.2)
The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)
Intervention MeSH terms: Efavirenz; Fosamprenavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The hope of this study is to gather data and information about the tolerability and
      effectiveness of Lexiva versus Sustiva in patients who have have been generally
      underrepresented in clinical trials.
    

Eligibility criteria:

        Inclusion Criteria:

        Screening plasma HIV-1 RNA viral load >5000 copies/mL Self-identification as having any
        non-White/Caucasian European geographic ancestry (i.e., an individual is eligible if she/he
        does not have any White/Caucasian European ancestry; OR an individual is eligible if she/he
        indicates a mix of White/Caucasian European ancestry AND one or more other geographic
        ancestries); Antiretroviral-naïve (no treatment with any antiretroviral drug in the 28 days
        prior to study entry and ≤14 days of treatment ever with any antiretroviral drug) Negative
        test for the HLA-B*5701 allele Ability and willingness to give written informed consent

        Either gender is eligible, but enrollment of at least two female subjects to every one male
        subject is strongly encouraged. A female subject is eligible to participate in the study if
        she is of:

          1. Non-childbearing potential or,

          2. Childbearing potential with a negative pregnancy test at screen and agrees to use one
             of the following methods of contraception:

        i. Agreement for complete abstinence from intercourse from 2 weeks prior to administration
        of investigational products, throughout the study, and for 2 weeks after discontinuation of
        all study medications; ii. Double barrier contraception (male condom/spermicide, male
        condom/diaphragm, diaphragm/spermicide); iii. Any intrauterine device (IUD) with published
        data showing that the expected failure rate is less than 1% per year (not all IUDs meet
        this criterion); iv. Any other method with published data showing that the lowest expected
        failure rate for the method is less than 1% per year. v. Sterilization (female subject or
        male partner of female subject)

        Exclusion Criteria:

        Screening HIV-1 genotype indicating the presence of any of the following mutations in the
        reverse transcriptase (RT) region: K65R, L74V, K103N, Y115F, Y181C/I, Y188C/L/H or G190S/A,
        or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E)
        that include changes at either L210 or T215, associated with resistance to abacavir,
        lamivudine, or efavirenz; OR within the protease region, detection of any of the following
        mutations associated with resistance to fosamprenavir or ritonavir: I50V, I54L/M, I84V, or
        the combination of the two mutations V32I+I147V Positive for Hepatitis B surface antigen
        (HBsAg+)

        Requirement for active treatment for hepatitis C virus infection, as indicated by both a
        positive Hepatitis C Virus serology AND either:

          1. Decompensated liver disease, or

          2. Aspartate aminotransferase (AST) >3X the upper limit of normal (ULN), or

          3. Alanine aminotransferase (ALT) >3X the ULN Currently pregnant, intending to become
             pregnant during the study period, or breast-feeding Use of immunomodulators (e.g.,
             interleukins, interferons, cyclosporine), any vaccinations, systemic cytotoxic
             chemotherapy, or investigational therapy within 28 days prior to study entry. Chronic
             treatment with prednisone at a daily dose of 10 mg or less is permitted. Acute
             treatment (less than 21 days) with larger doses of corticosteroids for acute therapy
             is permitted.

        Active or suspected drug or alcohol use or dependence that, in the opinion of the site
        investigator, would interfere with adherence to study requirements Judged by the
        investigator to be at significant risk of failing to comply with the provisions of the
        protocol as to cause harm to self or seriously interfere with the validity of the study
        results Active or acute Centers for Disease Control Clinical Category C event at screening.
        (Note: Treatment for the acute event must have been completed at least 28 days prior to
        screening.) Clinically relevant pancreatitis or clinically relevant hepatitis at screening
        Hgb<8g/dl, platelet count <50,000/mm3, calculated creatinine clearance <50ml/min via
        Cockroft-Gault equation, or AST or ALT > 5X the ULN Any Grade 4 laboratory abnormality