Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4) - VICTOR-E4

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 375

Inclusion Criteria

1. A subject must give written informed consent prior to screening for this study
2. A subject must be willing and able to adhere to dose and visit schedules
3. A subject must be at least 16 years of age (or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) at the time of randomization, of either sex, and of any race
4. A subject must be infected with HIV-1 virus, as documented by a positive assay for HIV-1 RNA in plasma, prior to Screening
5. A subject must have plasma HIV-1 RNA >1000 copies/mL within 60 days of randomization, either
a) on a stable regimen of 3 or more antiretroviral drugs for at least 4 weeks at time of Screening, OR
b) on no antiretroviral agents, for =4 weeks prior to Screening
6. Subjects must be ART-experienced and have documented resistance (as determined by the Monogram GeneSEq or PhenoSense HIV Drug Resistance assay) to at least 2 of the following 3 drug classes: NRTI, NNRTI or PI
OR
Antiretroviral class experience =6 months (sequential or cumulative) with at least two of the following:
a) one NRTI
b) one NNRTI
c) two PIs (excluding low dose ritonavir)
7. Subjects must be willing to begin newly optimized background therapy (OBT) containing at least 3 drugs at time of randomization, one of which must be a ritonavir-boosted PI. The OBT must contain at least 2 active drugs
8. QTc interval (corrected by the Bazett method) read by the Central EKG Cardiologist must be <470 msec for female subjects and <450 msec for male subjects. (Applicable only to subjects screening for the double-blind segment of the study)
9. Subjects must have acceptable hematologic, renal, and hepatic laboratory parameters: Platelet count =75,000/ µL; hemoglobin =9.0 g/dL; absolute neutrophil count =750/µL; serum creatinine =2 x ULN; AST (SGOT) and ALT (SGPT) =5 x ULN; alkaline phosphatase =5 x ULN; total bilirubin =2.5 x ULN. For subjects receiving indinavir or atazanavir, or known to have Gilbert’s syndrome, the total bilirubin must be =5 x ULN and in fractionation must demonstrate that the increase is due to an elevated indirect bilirubin. Subjects with chronic hepatitis B or C may be enrolled if they have stable liver disease and liver enzymes in the following ranges: AST (SGOT) and ALT (SGPT) =3 x ULN; alkaline phosphatase =5 x ULN; total bilirubin =2.5 x ULN
10. Women of child-bearing potential must agree to use a medically accepted method of contraception during the screening period, and while receiving protocol-specified medication.
Acceptable methods include:
a. condoms (male or female), with or without a spermicidal agent (Note: in some countries, use of spermicide with condoms may be required)
b. diaphragm or cervical cap with spermicide
c. sponge with spermicide
d. surgical sterilization (e.g., hysterectomy or bilateral oophorectomy)
11. Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. Post-menopausal women (having had no menses for =24 months) are exempted from the requirement for use of contraception.
12. A subject must be willing to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infection

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects

Exclusion Criteria

1) Subjects must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening (i.e. HIV isolate must be solely CCR5-tropic)

2) Subjects must not have any condition that, in the judgment of the investigator, is likely to increase the risk of seizures

3) Subjects must not have a prior history of malignancy (with the exceptions of surgically resected basal-cell carcinoma or cutaneous Kaposi's sarcoma without visceral or mucosal inlvolement that resolved without systemic anticancer treatment)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the hypothesis that vicriviroc 30 mg QD provides added benefit in plasma HIV-1 RNA reduction when added to optimized background therapy (OBT), as measured by the proportion of subjects with HIV RNA <50 copies/mL at Week 48.;Secondary Objective: To evaluate the safety and tolerability of vicriviroc compared to placebo, each in combination with OBT.;Primary end point(s): Proportions of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL by Ultrasensitive Amplicor HIV-1 Monitor Test, version 1.5) at 48 weeks will be compared to between vicriviroc and control groups as the primary measure of antiviral efficacy.

Secondary Outcome Measures

Name	Time	Method

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