Clinical trial NCT00511368 (phase 2, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: matching placebo, bevirimat
SMILES: CC1=CC(O)=CC(C)=C1Cl, [H][C@]12[C@@H](CC[C@@]1(CC[C@]1(C)[C@]2([H])CC[C@]2([H])[C@@]3(C)CC[C@H](OC(=O)CC(C)(C)C(O)=O)C(C)(C)[C@]3([H])CC[C@@]12C)C(O)=O)C(C)=C
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female. Females of child-bearing potential, must have a documented negative
             pregnancy test and be willing to utilize double-barrier contraception through-out the
             study period.

          -  Have HIV-1-infection.

          -  Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of
             2,000 - 250,000 copies/ml (inclusive).

          -  Have documented evidence of genotypic resistance in their medical records (at
             screening) or have resistance at screening by genotype to any major mutation from the
             IAS-USA list of resistance drug mutations, defined as: NRTI resistance: M41L, K65R,
             D67N, K70R, K70E, L74V, Y115F, M184V, M184V/I, L210W, T215Y/F, K219Q/E; NNRTI
             resistance: L100I, K103N, V106M, V106A/M, V108I, Y181C, Y181C/I, Y188L, Y188C/L/H,
             G190S/A, G190A, P225H; Major PI resistance: D30N, V32I, L33F, M46I/L, I47V/A, G48V,
             I50L, I50V, I54M/L, L76V, V82A/F/T, V82A/F/T/S, V82L/T, I84V, N88S, L90M

          -  Be receiving an antiretroviral therapy regimen containing at least 3 drugs (regimens
             containing ritonavir must not exceed a total daily dose of 400 mg) which has been
             unchanged for at least 8 weeks prior to initial screening.

          -  Be able to receive an optimized background regimen.

          -  Be free from any acute infection or serious medical illness within 14 days prior to
             study entry.

          -  Be informed of the nature of the study and provide written informed consent.

          -  Be willing to comply with the meal requirements described in the protocol.

        Exclusion Criteria:

          -  Current opportunistic infection characteristic of AIDS

          -  Patients unable or unwilling to comply with the dosing schedule and protocol
             evaluations.

          -  Patients with malabsorption syndromes affecting drug absorption.

          -  Patients with systolic blood pressure < 90 mmHg or > 140 mmHg or diastolic blood
             pressure < 60 mmHg or > 90 mmHg measured in a semi-recumbent position after at least
             10 minutes of rest at the screening or qualification visit.

          -  A history of seizures (excluding pediatric febrile seizures), migraines, cluster
             and/or chronic headaches, cerebrovascular accident (CVA) or transient ischemic attacks
             (TIA).

          -  Patients with abnormal Hemoglobin (< 10.0 g/dL for men and < 9.0 g/dL for women),
             Neutrophil count (< 1000/mm3), Platelet count (< 100,000/mm3), AST or ALT > 2.5 times
             the upper limit of normal (patients with a positive HBV surface antigen or HCV
             antibody test at screening must have AST and ALT no more than 1.5 times the upper
             limit of normal)

          -  Patients who have received radiation therapy or cytotoxic chemotherapeutic agents,
             immunomodulating agents, HIV immunotherapeutic vaccine, an investigational drug or
             product, or participation in a drug study within 4 weeks prior to the first dose of
             study drug.

          -  A history of alcoholism or drug addiction within the past 1 year (unless enrolled in a
             treatment program and approved by the sponsor). Recent use of any recreational drugs
             (except marijuana).

          -  A history of difficulty donating blood or inadequate venous access.

          -  The donation of blood or plasma within 30 days prior to receiving study medication.

        Note: patients with a CD4 count <100 cells/mm3 will be considered for enrollment following
        discussion and agreement between the Investigator and the Sponsor.