Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay

Phase 1TerminatedNCT00496782

ViiV Healthcare16 enrolled

Overview

The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.

The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

maravirocDRUG

Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Trofile Assay and HIV RNA quantification assayPROCEDURE

Trofile Assay and HIV RNA quantification assay

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit. * Have an HIV RNA ≥ 1000 copies/mL, at screening. * Subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided. * That the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance), * Neither protocol prohibits the use of the other antiretroviral agent, AND the dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents. * Based on screening genotypic resistance testing results the subject must be able to receive at least 3 active drugs other than maraviroc in the new OBT. This is defined as: * Having three drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility); or, * Having two drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility) and be willing to include raltegravir in the OBT not having used raltegravir in the past. Exclusion Criteria: * Potentially life threatening (Grade 4) laboratory abnormality or medical condition. * Severe hepatic impairment (Child-Pugh classification B or C). * End stage renal disease or other disease states requiring dialysis therapy.

Locations (10)

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Topeka, Kansas, United States

Outcomes

Primary Outcomes

Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay

Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism

Time frame: Baseline, Day 4, 7, 14

Secondary Outcomes

Subjects Achieving HIV-1 RNA <400 Copies/mL

Number of Subjects Achieving HIV-1 RNA \<400 Copies/mL at each time point

Time frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24

Subjects Achieving HIV-1 RNA <50 Copies/mL

Number of Subjects Achieving HIV-1 RNA \<50 Copies/mL at each time point

Time frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24

Subjects With Virologic Failure

For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA \> 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification \[LOQ\]); 2. Experiencing a \> 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline \> 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA \>1000 copies/mL after having achieved an HIV-1 RNA below LOQ.

Time frame: Baseline up to Week 24

Time to Virologic Failure

Data from ClinicalTrials.gov

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