Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00098722
• Date of registration: 07/12/2004
• Primary sponsor: ViiV Healthcare
• Public title: Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects MOTIVATE 2
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
• Date of first enrolment: December 2004
• Target sample size: 474
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00098722
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or women at least 16 yers of age (or minimum age as determined by local
regulatory authorities)

- HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL

- Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least
4 weeks

- Documented genotypic or phenotypic resistance to three of the four antiretroviral
drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months
(sequential or cumulative) with at least three of the following: One nucleoside or
nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase
inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide

- Be willing to remain on randomized treatment without any changes or additions to the
OBT regimen, except for toxicity management or upon meeting criteria for treatment
failure

- A negative urine pregnancy test at the baseline visit for Women of Child Bearing
Potential (WOCBP)

- Effective barrier contraception for WOCBP and males

Exclusion Criteria:

- Patients requiring treatment with more than 6 antiretroviral agents (excluding
low-dose ritonavir)

- Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry
inhibitor for more than 14 days

- Suspected or documented active, untreated HIV-1 related opportunistic infection (OI)
or other condition requiring acute therapy

- Treatment for an active opportunistic infection, or unexplained temperature >38.5
degrees Celsius for 7 consecutive days

- Active alcohol or substance abuse sufficient, in the Investigator's judgment, to
prevent adherence to study medication and/or follow up

- Lactating women, or planned pregnancy during the trial period

- Significant renal insufficiency

- Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic
and/or cytotoxic agent within 60 days prior to randomization or the expected need for
such therapy during the study period

- Documented or suspected acute hepatitis or pancreatitis within 30 days prior to
randomization

- Significantly elevated liver enzymes or cirrhosis

- Significant neutropenia, anemia or thrombocytopenia

- Malabsorption or an inability to tolerate oral medications

- Certain medications

- Malignancy requiring parenteral chemotherapy that must be continued for the duration
of the trial

- X4- or dual/mixed-tropic virus or repeated assay failure

- Any other clinical condition that, in the Investigator's judgement, would potentially
compromise study compliance or the ability to evaluate safety/efficacy



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Maraviroc (UK-427,857)

Drug: optimized background therapy

Primary Outcome(s)

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48 [Time Frame: Baseline and Week 48]

Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline [Time Frame: Baseline]

Secondary Outcome(s)

Change From Baseline in CD4 Cell Count at Week 24 and 48 [Time Frame: Week 24 and 48]

Change From Baseline in CD8 Cell Count at Week 24 and 48 [Time Frame: Week 24 and 48]

Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening [Time Frame: Baseline, Week 24 and Week 48]

Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline [Time Frame: Baseline]

Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24 [Time Frame: Baseline and time of failure through Week 24]

Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48 [Time Frame: Baseline and time of failure through Week 48]

Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24 [Time Frame: Screening and time of failure through Week 24]

Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48 [Time Frame: Screening and time of failure through Week 48]

Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening [Time Frame: Screening]

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL [Time Frame: Week 24 and 48]

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline [Time Frame: Week 24 and 48]

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline [Time Frame: Week 24 and 48]

Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL [Time Frame: Week 24 and 48]

Time to Virological Failure [Time Frame: Week 48]

Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels [Time Frame: Baseline to Week 24 and Week 48]

Secondary ID(s)

A4001028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer