None listed
Conditions
Interventions
Group 1 Type of group
Vicriviroc maleate tablets 30 mq administered orally, once a day for 48 weeks
Group name:Group 2 Type of group
Similar placebo tablets administered orally, once a day for 48 weeks
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Subjects must give written informed consent before participating in the selection for this study. • Must be able to comply with dose schedules and visits and be willing to do so. • Must be at least 16 years of age (or the minimum age to define an adult as determined by legal requirements or local regulatory authorities) at the time of randomization, and belong to any sex and race. • They must have HIV-1 infection, documented by a positive HIV plasma test before screening. • They must have HIV RNA in plasma of> 1000 copies / mL during their current stable regimen at the time of selection. • They must be in treatment with a stable regimen of 3 or more antiretroviral drugs for at least 4 weeks at the time of selection. • The isolated HIV strain of the subjects must have dual / mixed tropism R5 / X4 in the Selection. • 8 The subjects must have received antiretroviral treatment beforehand and present genotypic resistance and / or a drug in 2 of the following 3 drug classes: NRTl, NNRTI, or Kl must have received antiretroviral treatment previously for at least 6 months (sequence! Or cumulative) with at least two of the following options: a) an NRTI. b) an NNRTI. c) two Pis (excluding ritonavir in low doses). • In the opinion of! investigator, the best treatment regimen for the subject should be an optimized antiretroviral regimen composed of> 3 drugs, including a protease inhibitor reinforced with> 100 mg ritonavir QD The regimen should contain at least 2 active drugs, based on the sensitivity test, and it can not contain an NNRTI. • 10 The QTc interval (corrected by the Bazett method) should be 75,000 / ml; hemoglobin> 9.0 g / dl; Absolute neutrophil count> 750 / ml; serum creatinine 24 months) are exempt from the contraceptive requirement. • Subjects should be willing to initiate chemoprophylaxis guided by the CD4 cell count to avoid opportunistic infections
Exclusion criteria
Exclusion criteria: • Subjects with tropism virus only X4 or only R5 in the Selection. • 2 Subjects with current malignancy or history of malignancy except cutaneous Kaposi´s sarcoma without involvement of mucous membranes or viscera that has disappeared with high activity antiretroviral therapy [HAART] but without systemic oncological treatment, and basal cell carcinoma of surgically excised skin with disease-free margins in the anatomopathological examination); or who have previously received cytotoxic chemotherapy for cancer that may increase the risk of malignancy. • Subjects with seizure disorders who require permanent anticonvulsant therapy or who have a condition that, in the opinion of the investigator, is likely to increase the risk of seizures (eg, malignant neoplasms of the CNS or toxoplasmosis). • Subjects with a CD4 cell count- 4 weeks and / or within 30 days prior to the Screening visit. • Concomitant participation in studies with other agents in research or use of said agents (except antiretroviral agents available through pre-approved access programs. • Subjects who have received any of the treatments detailed in Table 3 more recently than the pharmacological rest period (wash out) Indicated prior to the Selection or who must continue receiving some detailed treatment in Table 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HIV RNA (log10 copies / mL) Measure:Change with respect to the start in HIV RNA (log10 copies / mL) in Week 48. Timepoints:Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of CD4 count in Week 24 and Week 48. Measure:change with respect to the beginning of the CD4 count in Week 24 and Week 48. Timepoints:Week 24 and Week 48. ; Outcome name:Measurement of basal HIV RNA (log10 copies / mL) at 24 weeks. Measure:Change with respect to basal HIV RNA (log10 copies / mL) at 24 weeks. Timepoints:24 weeks. ; Outcome name:Measurement of HIV RNA in Week 24 and Week 48 Measure:Proportion of subjects with <400 copies / mL of HIV RNA in Week 24 and Week 48 Timepoints:Week 24 and Week 48 ; Outcome name:Measurement of HIV RNA in Week 24 and Week 48 Measure:Proportion of subjects with <50 copies / mL of HIV RNA in Week 24 and Week 48 Timepoints:Week 24 and Week 48 ; Outcome name:Proportion of subjects with AIDS defining events in Week 24 and Week 48 Measure:Proportion of subjects with AIDS defining events in Week 24 and Week 48 Timepoints:Week 24 and Week 48 | — |
Countries
Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Peru, Puerto Rico, United States
Contacts
Public ContactALFREDO PAREDES
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed