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

NCT00496782 | Terminated Phase 1 Results

• 1 other identifier: A4001060
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Day 4, 7, 14

Secondary Outcomes (13)

• Subjects Achieving HIV-1 RNA <400 Copies/mL

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

• Subjects Achieving HIV-1 RNA <50 Copies/mL

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

• Subjects With Virologic Failure

  Baseline up to Week 24

• Time to Virologic Failure

  Baseline up to Week 24

• Change in Lymphocyte Subset CD4 From Baseline

  Day 1 (Baseline), Day 7, 14, 28 and Weeks 24

Study Arms (1)

Single

OTHER

Drug: maraviroc; Procedure: Trofile Assay and HIV RNA quantification assay

Interventions

maraviroc DRUG

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.

Single

Trofile Assay and HIV RNA quantification assay PROCEDURE

Trofile Assay and HIV RNA quantification assay

Single

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (10)

Pfizer Investigational Site

Miami, Florida, 33137, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60613, United States

Location

Pfizer Investigational Site

Topeka, Kansas, 66606-1670, United States

Location

Pfizer Investigational Site

Topeka, Kansas, 66606, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68198-5400, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14215, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, 74135, United States

Location

Pfizer Investigational Site

Hampton, Virginia, 23666, United States

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 5B1, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study terminated prematurely due to slow enrollment. Premature termination of study was not due to any safety concerns. Efficacy data not summarized due to low sample size; only safety was summarized.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 30, 2019
• Results First Posted: March 19, 2010

Record last verified: 2019-01

Locations

US (9); CA (1)