Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098748
Status:
COMPLETED
Last Update Posted:
2010-12-07
First Post:
2004-12-07
Brief Title:
Trial of Maraviroc UK-427857 in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Novel CCR5 Antagonist UK-427857 in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced Non CCR5-Tropic HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Maraviroc UK-427857 a selective and reversible CCR5 co-receptor antagonist has been shown to be active in vitro against a wide range of clinical isolates including those resistant to existing classes In HIV-1 infected patients in the United States maraviroc UK-427857 is approved for use as part of combination antiretroviral treatment in treatment-experienced and treatment-naive adult subjects At least 50 of treatment-experienced patients are infected with R5-tropic HIV-1 exclusively However even in patients infected with a dual tropic R5 X4 phenotype a large proportion of the virus population still uses CCR5 exclusively Thus the purpose of this study is to evaluate the antiretroviral activity and safety of maraviroc UK-427857 in combination with other agents in HIV infected treatment experienced patients who are failing their current antiretroviral regimen and not infected with R5-tropic virus exclusively This study will involve more than 200 centers globally to achieve a total randomized subject population of 192 subjects Patients will be randomly 111 assigned to one of three groups Optimized Background Therapy OBT 3-6 drugs based on treatment history and resistance testing maraviroc UK-427857 150 mg taken once daily OBT maraviroc UK-427857 150 mg taken twice daily or OBT alone Randomization was stratified by Enfuvirtide use in OBT yesno and Screening HIV-1 RNA level viral load 100000 100 000 copies per milliliter copies per mL The study will enroll over approximately a 9 month period with 48 weeks of treatment Physical examinations will be performed at study entry weeks 4 8 12 16 20 24 32 40 and 48 Blood samples will also be taken at study entry weeks 2 4 8 12 16 20 24 32 40 and 48 Additionally blood samples will be drawn twice at least 30 minutes apart at weeks 2 and 24 for maraviroc UK-427857 pharmacokinetic analysis As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis Patients will undergo a 12-lead electrocardiogram at study entry weeks 24 and 48
Detailed Description:
i Subjects remained on their assigned therapy for 48 weeks unless the subject was discontinued early for protocol-defined treatment failure or other reasons such as adverse event loss to follow-up withdrawal of consent or death
ii If a subject met the criteria for treatment failure or discontinued for another reason eg pregnancy adverse event and required an alternative regimen the subject was followed until the Week 48 visit according to protocol guidelines The new regimen selected by the Investigator based on the results of resistance testing at the time of failure had to be recorded in the CRF
iii Open-label maraviroc UK-427857 was provided by the sponsor until it was commercially available to subjects who completed 48 weeks of therapy and for whom it was medically appropriate to continue therapy with maraviroc UK-427857
ii If a subject met the criteria for treatment failure or discontinued for another reason eg pregnancy adverse event and required an alternative regimen the subject was followed until the Week 48 visit according to protocol guidelines The new regimen selected by the Investigator based on the results of resistance testing at the time of failure had to be recorded in the CRF
iii Open-label maraviroc UK-427857 was provided by the sponsor until it was commercially available to subjects who completed 48 weeks of therapy and for whom it was medically appropriate to continue therapy with maraviroc UK-427857
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None