Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED)

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-103-07
• Lead Sponsor: SCHERING PLOUGH DEL PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 <470 msec for women and <450 msec for men in the Selection.
• Subjects must present hematological laboratory values. Renal and hepatic acceptable in the Selection; Platelet count> 75,000 / ml; hemoglobin> 9.0 g / dl; Absolute neutrophil count> 750 / ml; serum creatinine <2 times the ULN (upper limit of normal): AST (SGOT) and ALT (SGPT) <3 times the ULN and alkaline phosphatase <5 times the ULN; Total bilirubin <2.5 X ULN. In the case of subjects who receive indinavir or atazanavir or who are known to have Gilbert´s syndrome, the total antibody must be <5 times ULN and fractional must show that the increase is due to a high indirect bilirubin. Subjects with chronic hepatitis B or C may be included if they have stable liver disease and liver enzymes within the following ranges: AST (SGOT) and ALT (SGPT) <3 times the ULN; alkaline phosphatase <5 times the ULN; total bilirubin <2.5 times ULN.
• Women of childbearing age must agree to use a medically accepted method of contraception before receiving the medication specified by the protocol and for 2 months after stopping the medication. Acceptable methods are considered: a. condoms (male or female), with or without spermicidal agent b. diaphragm, sponge or cervical cap with spermicide c. medically prescribed intrauterine device (IUD) d. surgical sterilizationGa- (pQr-ej.-hysterectomy-tubal ligation-bilateral uovariectomy)
• Procreating women who are not having sex should agree to use a medically acceptable method of contraception if they decide to have sex while participating in the study. Postmenopausal women (who have not dyed menses for> 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

• 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- <50 cells / mm3 in the selection
• Subjects whose use of any drug (therapeutic or recreational) represents an increased risk of seizures, according to the opinion of the researcher.
• Subjects with a serious illness, such as an active disease defining AIDS that requires systemic treatment and / or hospitalization. When at the discretion of the investigator, a subject of this type is clinically stable for at least 8 weeks before Day 1, randomization may be preceded. It may be necessary to repeat the laboratory tests of the selection before the incorporation of the subject.
• Subjects with proven liver cirrhosis or symptoms, clinical signs or alterations in laboratory values ​​compatible with cirrhosis. Subjects with chronic hepatitis B or C can be incorporated if they have stable liver disease and liver enzymes within the range of inclusion criteria.
• Subjects with intercurrent disease, vaccinations or who have used immunomodulators (within 2 weeks prior to Screening) that could influence plasma levels of HIV RNA.
• Subjects who have been previously enrolled in a clinical study with vicriviroc or who have previously received a CCR5 antagonist for> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified