None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Vicriviroc, in tablets, at a dose of 30 mg, PO, QD + An optimal antiretroviral therapy containing Ritonavir, at the discretion of the researcher, for 48 weeks.
Group name:GROUP 2 Type of group
This group will be treated with Vicriviroc Placebo, in tablets, PO, QD + An optimal antiretroviral therapy containing Ritonavir, at the discretion of the researcher, for 48 weeks.
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject must give written informed consent before entering the selection stage for this study. 2. The subject must be willing and able to comply with the schedules of administration of doses and visits. 3. The subject must be at least 16 years of age at the time of randomization and be of any sex or race. 4. The subject must be infected with the HIV-1 virus. 5. The subject must present> 1000 copies / ml of HIV-1 RNA in plasma within 60 days of randomization. 6. Subjects must have received antiretroviral therapy (ART) beforehand and have confirmed resistance to at least 2 of the following 3 classes of drugs; NRTls, NNRTls or lPs. Or have been treated for at least 6 months with each of the following classes of antiretrovirals: NRTls, NNRTls, IPs. 7. Subjects should be willing to start a new optimized base treatment (OBT) that contains at least 3 drugs at the time of randomization. 8. The QTc interval should be <470 ms for women and <450 ms for men. 9. Subjects must present acceptable hematological, renal and hepatic laboratory values. 10. Women of childbearing age should agree to use a contraceptive method accepted medically. 11. Women of childbearing age who are not having sex should agree to use a contraceptive method medically accepted if they become sexually active during their participation in the study. Postmenopausal women are exempt from the requirement to use contraceptives 12. The subject must be willing to start chemoprophylaxis.
Exclusion criteria
Exclusion criteria: 1. Subjects with strains of HIV with tropism CXCR4 or tropism CCR5 / CXCR4 dual / mixed detectable in the selection stage. 2. Subjects with a history of cancer. 3. Subjects with seizure disorders requiring continued anticonvulsant therapy or with any condition that may increase the risk of seizures. 4. Subjects whose use of any drug, or in whom abstinence from it presents an increased risk of seizures. 5. Subjects with a serious illness. 6. Subjects with known liver cirrhosis or with symptoms, clinical signs, or abnormal laboratory values ​​indicative of cirrhosis. 7. Subjects with intercurrent diseases, who have received vaccines or used immunomodulators that could influence plasma HIV-1 RNA levels. 8. Subjects who have previously been enrolled in any clinical trial with vicriviroc or who have previously used a CCR5 Inhibitor for> 4 weeks and / or within 30 days of the Screening visit. 9. Subjects who have received any of the certain prohibited treatments while they are still in the indicated washout period. 10. Subjects with allergy / hypersensitivity to the study drug or its excipients. 11. Women who are breastfeeding, pregnant or who intend to become pregnant. 12. Subjects with any clinically relevant condition or situation other than the condition being studied. 13. Subjects that are members or relatives of staff members directly involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Peripheral blood levels to detect levels of HIV-1 RNA. An undetectable level is defined as <50 copies / ml. The Ultrasensitive Amplicor HIV-1 Monitor, Version 1.5 technique will be applied. Measure:Proportion of subjects with undetectable HIV-1 RNA. Timepoints:Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Ultrasensitive Amplicor HIV-1 Monitor Trial, Version 1.5. for the detection of the number of copies of the amount (in log10) of HIV-1 RNA. Measure:Secondary efficacy: 1) Mean change in the baseline value of HIV-1 RNA in plasma. 2) Proportion of subjects with <400 copies / ml of HIV-1 RNA in plasma. 3) Proportion of subjects with a reduction ≥ 2 log10 of the baseline value of HIV-1 RNA. Timepoints:Week 48. ; Outcome name:Criterion 1: Peripheral blood levels to detect levels of HIV-1 RNA. An undetectable level is defined as <50 copies / ml. The Ultrasensitive Amplicor HIV-1 Monitor, Version 1.5 technique will be applied. Criterion 2: Serum levels of CD4 T lymphocytes. Measure:Other criteria: 1) Time to loss of virological response (TLOVR). 2) Average change of the CD4 + count with respect to the Start. Timepoints:Week 48. ; Outcome name:Criterion 1: Resistance is determined by the HIV resistance test to the Monogram GeneSEq or PhenoSense drugs. Criteria 2 and 3: Detection of the appearance of tropism for CXCR4 and / or CCR5. Measure:Virological Safety: 1) Frequency of the appearance of viral resistance to vicriviroc or other components of the regimen. 2) Frequency of the appearance of tropic virus to CXCR4 or with dual CCR5 / CXCR4 / mixed tropism detectable. 3) Frequency of the appearance of tropic virus to CXCR4 or with dual CCR5 / CXCR4 tropism / mixed detectable with a considerable reduction below the basal value of the CD4 + count. Timepoints:Before starting the treatment. ; Outcome name:Criterion 1: Adverse clinical experiences are considered: a) At least 1 adverse event (AD). b) At least 1 serious EA. c) Withdrawal due to an EA. d) EAs grades 3/4. Criterion 2: Abnormal laboratory results associated with: 1) Intervention requirement or additional treatment. 2) Association with a clinical manifestation. Measure:Clinical Safety: 1) Proportions of subjects with adverse clinical experien | — |
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