SSAT046 Addition of Maraviroc to monotherapy Darunavir/Ritonavir study
- Conditions
- HIV infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-000649-11-ES
- Lead Sponsor
- St Stephen's AIDS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. male or female aged between 18 and 65 years
2. has a documented HIV-1 infection
3. has signed the Informed Consent Form voluntarily
4. is willing to comply with the protocol requirements
5. has an HIV-plasma viral load at screening <40 copies/mL (one off retesting for blips <200 copies/ml is allowed)
6. has a CD4 cell count at Screening >200 cells/mm3
7. has been on a stable darunavir/ritonavir regimen 800/100 once daily alone for at least 12 weeks at Screening, and willing to remain on this;
8. estimated glomerular filtration rate (by MDRD or CG methods) >60 ml/min at screening
9. CCR5 tropic by geno2pheno assay performed at screening
10. 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
11. 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. is infected with HIV-2
2. is using any concomitant therapy disallowed as per SPC for the study drugs (section 5.2)
3. 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
Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed
4. has acute viral hepatitis including, but not limited to, A, B, or C
5. has chronic hepatitis B and/or C
6. has received any investigational drug within 30 days prior to the trial drug administration
7. Clinically significant allergy or hypersensitivity to any trial medication excipients
8. If female, she is pregnant or breastfeeding
9. 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).
10. Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN.
11. Platelets of < 50 based on screening blood results.
12. 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 Main Objective: ? To investigate changes from week 12 to week 36 in inflammatory markers in CSF when maraviroc (150mg qd) is added to stable darunavir/ritonavir (800/100mg qd) monotherapy for 24 weeks;Secondary Objective: ? To investigate the occurrence of viral load blips whilst on darunavir/ritonavir plus maraviroc<br>? To investigate changes in CD4 count <br>? To investigate changes in neurocognitive function<br>? To assess the safety and tolerability of darunavir/ritonavir plus maraviroc<br>? To look at MRI brain changes over the course of the study<br>? To examine drug levels of darunavir, maraviroc and ritonavir in CSF (and paired plasma samples);Primary end point(s): ? Change from week 12 to week 36 in inflammatory markers in CSF when maraviroc (150mg qd) is added to stable darunavir/ritonavir (800/100mg qd) monotherapy for 24 weeks;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? Frequency of viral load blips whilst on darunavir/ritonavir plus maraviroc<br>? Changes in CD4 count from baseline to week 12 and week 12 to week 36 <br>? Changes from control phase (baseline- Week 12) and week 36 in neurocognitive scores<br>? Proportion of subjects experiencing grade 2-4 clinical adverse events (at least possibly drug-related) at baseline, week 12, week 16 and week 36<br>? Proportion of subjects experiencing grade 2-4 laboratory abnormalities at baseline, week 12, week 16 and week 36<br>? Changes in MRI brain scanning over 36 weeks<br>? Drug concentrations of darunavir, ritonavir and maraviroc at week 36 in CSF (compared to matched plasma samples calculated as plasma:CSF ratio);Timepoint(s) of evaluation of this end point: 16, 24 and 36 weeks