A study to find out whether maraviroc given once daily is as effective as Truvada given once daily in treating HIV-infected patients never previously treated with maraviroc.

• Conditions: HIV infection; MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-021785-30-DE
• Lead Sponsor: ViiV Healthcare UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-16
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study
2. At least 18 years of age at the Screening Visit.
3. Plasma HIV 1 RNA equal to or more than 1,000 copies/mL measured at the Screening Visit.
4.CD4 count equal to or more than 100 cells/mm3 at Screening.
5.Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.
6.A negative urine pregnancy test at Screening and at the Baseline Visit, prior to receiving the first dose of study medication, for Women of Child Bearing Potential (WOCBP).
NOTE: WOCBP include any female who has experienced menarche and who has not undergone hysterectomy, bilateral oophorectomy or tubal ligation or any other successful surgical sterilization or is not post menopausal (age >45 years, amenorrheic for >2 years, and serum FSH levels >30 IU/L). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods: eg. condom or diaphragm with spermicidal) to prevent pregnancy, who are practising abstinence, or who have a partner that is sterile (eg, vasectomy), should be considered to be of child bearing potential.
7.WOCBP, male study subjects and their partners must use two forms of contraception one of which is effective barrier contraception throughout the study and for at least 28 days following the last dose of study medication. WOCBP must use another acceptable method of contraception from screening to at least 28 days after the trial. Acceptable contraception includes the following:
•Oral, transdermal, implantable, or injectable hormone therapy;
•Effective intrauterine devices;
•Vasectomized partner;
•Double barrier contraceptive methods.
8.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
9.Subjects who have consented to participate in the DEXA scan sub study must be equal to or less than 136 kg (300 lb) in weight and equal to or less than 1.95 m (6ft. 4.8 inches) in height and have a body mass index equal to or less than 40 kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Suspected or documented active, untreated HIV 1 related Opportunistic Infection (OI) or other condition requiring acute therapy (eg, acute hepatitis C virus infection) at the time of randomization to treatment. [Subjects on a stable (>1 month) secondary OI prophylaxis regimen or chronic treatment with stable disease (eg, for hepatitis C virus infection) are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study].
2. Treatment for an active opportunistic infection, or unexplained temperature >38.5°C (101.3º F) for 7 consecutive days, within 30 days prior to screening.
3. Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
4. Active alcohol consumption equal to or more than 30 g ethanol per day in males and equal to or more than 20 g per day in females.
5. Substance abuse sufficient, in the Investigator’s judgment, to prevent adherence to study medication and/or Follow Up.
6. Lactating women or planned pregnancy during the study period.
7. Initiation of therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to screening or the expected need for such therapy during the study period.
8. Malignancy requiring parenteral or oral chemotherapy that must be continued for the duration of the study.
9. Documented or suspected acute hepatitis or pancreatitis within 30 days prior to Randomization
10. Renal insufficiency defined as a serum creatinine greater than 3 times the upper limit of normal or a creatinine clearance of less than 50 mL/min, as calculated by the Cockcroft and Gault equation.
11. Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences.
12. ALT equal to or more than 5.0xULN;
13. Subjects with chronic Hepatitis B (HBsAg positive).
14. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
15. Clinically significant malabsorption syndrome (eg, equal to or more than 6 loose stools per day for at least 7 consecutive days) within 30 days prior to Screening.
16. Inability to tolerate oral medication.
17. Concomitant therapy with other investigational agents.
18. The following medications being taken by the subject at the time of randomization to treatment that must be continued during the study period, including immunomodulators (for the treatment of HIV 1 infection), and any contraindicated medication described in the package inserts of maraviroc (Selzentry, Celsentri), darunavir (Prezista), ritonavir (Norvir) and emtricitabine/tenofovir (Truvada).
19. Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
20. CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.
21. Any safety, behavioral, clinical, or administrative reasons that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
22. Have a known hypersensitivity to darunavir, ritonavir, tenofovir, emtricitabine, to maraviroc or any of its excipients, including soy lecithin or dyes of those dr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified