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 infectionMedDRA version: 14.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-021785-30-IT
- Lead Sponsor
- VIIV HEALTHCARE UK LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 804
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: 0
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
1.Suspected or documented active, untreated HIV 1 related Opportunistic Infection or other condition requiring acute therapy at the time of randomization to treatment 2.Treatment for an active opportunistic infection, or unexplained temperature >38.5°C 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 = 30 g ethanol per day in males and =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 3xULN or a creatinine clearance of less than 50 mL/min 11.Potentially life threatening (Grade 4) laboratory abnormality or medical condition 12.ALT equal to or more than 5.0xULN 13.Subjects with chronic Hepatitis B (HBsAg positive) 14.Unstable liver disease, known biliary abnormalities 15.Clinically significant malabsorption syndrome 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, and any contraindicated medication described in the package inserts of maraviroc, darunavir, ritonavir and emtricitabine/tenofovir 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 drugs as described in the package inserts, or known hypersensitivity/allergy to peanuts 23.Participation in other interventional studies within 30 days before the current study begins and/or during study participation 24.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient subject inappropriate for entry into this study 25.Subjects who are investigational site staff members or subjects who are the Sponsor's employees directly involved in the conduct of the trial 26.Subjects who have consented to participate in the DEXA scan sub study who have implants in the lumbar spine or have multiple vertebral fracture or severe degenerative disease in the range L1L4 which prevents reliable spine BMD measure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method