SSAT046 Addition of Maraviroc to monotherapy Darunavir/Ritonavir study
- Conditions
- HIV
- Registration Number
- EUCTR2012-000649-11-GB
- Lead Sponsor
- St Stephen's Aids Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 19
- male or female aged 18 years or above.
- has a documented HIV-1 infection.
- has signed the Informed Consent Form voluntarily.
- is willing to comply with the protocol requirements.
- has an HIV-plasma viral load at screening <40 copies/mL (one off retesting for blips <200 copies/ml is allowed).
- has a CD4 cell count at Screening >50 cells/mm3.
- has been on a stable DRV/r alone for at least 12 weeks at Screening, and willing to remain on this.
- estimated glomerular filtration rate (by MDRD or CG methods) >50 ml/min at screening.
- CCR5 tropic by geno2pheno assay performed at screening.
- if female and of childbearing potential, she is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs). Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential.
- if a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit.
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
- is infected with HIV-2.
- is using any concomitant therapy disallowed as per SPC for the study drugs.
- has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions (must be discussed with the Investigator prior to enrolment).
- Stable cutaneous Kaposi’s Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions) unlikely to require systemic therapy during the trial period.
- CD4 count less than 200 cells/mm3.
Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed.
- has acute viral hepatitis including, but not limited to, A, B, or C.
- has chronic hepatitis B and/or C.
- has received any investigational drug within 30 days prior to the trial drug administration.
- Clinically significant allergy or hypersensitivity to any trial medication excipients.
- If female, she is pregnant or breastfeeding.
- Screening blood results with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
- Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN.
- Platelets of < 50 based on lumbar puncture examination at baseline.
- Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
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