Vicriviroc (SCH 417690) in the Combined Treatment with an Optimized Antiretroviral Regimen in Subjects with Previous Antiretroviral Therapy (Study VICTOR-E1)

Not Applicable

• Registration Number: PER-054-05
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Subjects must be adults (> 18 years old) of either sex and of any race.
2. Subjects must have an HIV infection confirmed by a positive analysis of HIV RNA in plasma prior to Selection.
3. In the Selection phase, the HIV strain of each of the subjects should be tropic to R5 only.
4. In the opinion of the researcher, the best treatment regimen for the subject should be an optimized ART regimen composed of> 3 drugs, including an IR, reinforced with> 100 mg of ritonavir QD.
5. Treatments with a ART regimen> 3 months duration, the HIV RNA levels of the subjects should be> 5000 copies / ml.
6. Subjects must have been treated previously for> 3 months with> 3 classes of antiretroviral agents currently marketed.
7. The HIV genotype of the subjects should have> 1 mutation of resistance to the nucleoside reverse transcriptase inhibitor / nucleotide class and> 1 primary mutation of resistance to the IP class.
8. Subjects must present acceptable hematological, renal and hepatic laboratory values.
9. Subjects must be exempt from any disease, condition or clinically relevant situation.
10. Women in conditions of procreation should have a negative serum pregnancy test.
11. Women in conditions of procreation should agree to use a medically accepted method of contraception.
12. Women who are able to procreate who are not having sex should agree to use a medically acceptable method of contraception.
13. The subjects must be willing to give their informed consent in writing and able to comply with the schedules of visits and administration of the doses.

Exclusion Criteria

1. Subjects with detectable X4 or R5 / X4 virus.
2. Subjects with a history of recurrent seizure disorders of any kind.
3. Subjects with an injury or illness of the CNS that predisposes them to having seizures.
4. Subjects whose use of any drug represents an increased risk of seizures.
5. Chronic addiction to an agent that could increase the risk of seizures when removing said agent in the Selection or during the study.
6. Subjects with a serious illness, such as an active opportunistic infection defining AIDS that requires systemic treatment and / or hospitalization in a hospital.
7. Subjects with any clinically relevant condition or situation other than the condition being studied.
8. Subjects with intercurrent disease, vaccinations or who have used immunomodulators.
9. Subjects with allergy / sensitivity to the study drug or its excipients.
10. Women who are breastfeeding, pregnant or who intend to become pregnant.
11. Subjects who are participating in any other clinical study, unless specifically approved by the project´s physician.
12. Subjects who are members or family members of the staff of the team directly involved in this study.
13. Subjects who have previously used a CCR5 inhibitor for> 4 weeks and / or within 30 days of the Screening visit.
14. Subjects who have received any of the treatments detailed in Table 3.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:HIV RNA made with PCR.<br>Measure:Antiviral efficacy: Percentage of subjects with a decrease greater than or equal to log10 of viral RNA at 24 weeks.<br>Timepoints:Day 1, weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:HIV RNA made with PCR.<br>LT CD 4 count.<br>Clinical evaluation.<br>Measure:Time to virological failure. Percentage of subjects with <400 copies of HIV RNA. Percentage of subjects with <50 copies of HIV RNA. Lymphocyte count. Clinical defining episodes of AIDS.<br>Timepoints:Day 1, weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48.<br>;<br>Outcome name:Appearance of viral resistance. appearance of tropism to CXCR4.<br><br>Measure:Virological security.<br><br>Timepoints:Day 1 weeks 12, 20 and 48.<br>;<br>Outcome name:Pharmacokinetics and pharmacodynamics in peripheral blood samples of a subgroup of patients.<br><br>Measure:Pharmacological evaluation.<br><br>Timepoints:Weeks 4, 24.<br>