HIV
Conditions
Interventions
Trade Name: Prezista
Product Name: Darunavir
Pharmaceutical Form: Capsule, hard
Other descriptive name: darunavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80
Sponsors
St Stephen's Aids Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 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
Exclusion criteria
Exclusion criteria: - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate changes from week 12 to week 36 in levels of inflammation within the fluid that surrounds the Central Nervous System, called cerebrospinal fluid or CSF, when maraviroc is taken along with regular darunavir/ritonavir monotherapy for 24 weeks. ;Secondary Objective: To investigate change from baseline to week 12 in levels of inflammation in CSF on darunavir/ritonavir monotherapy (control phase). To investigate the occurrence of viral load level blips (short term changes) whilst on darunavir/ritonavir plus maraviroc. To investigate changes in CD4 count (marker of immune system). To investigate changes in neurocognitive function (brain functioning). To assess the safety and tolerability of darunavir/ritonavir plus maraviroc. To look at MRI brain changes over the course of the study. To examine drug levels of darunavir, maraviroc and ritonavir in CSF.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to week 12 in CSF inflammatory markers on darunavir/ritonavir monotherapy (control phase). Frequency of viral load blips whilst on darunavir/ritonavir plus maraviroc. Changes in CD4 count from baseline to week 12 and week 12 to week 36. Changes from control phase (baseline-week12) and week 36 in neurocognitive scores. Proportion of subjects experiencing grade 2-4 clinical adverse events (at least possibly drug-related) at baseline, week 12, week 16 and week 36. Proportion of subjects experiencing grade 2-4 laboratory abnormalities at baseline, week 12, week 16 and week 36. Changes in MRI brain scanning over 36 weeks. Drug concentrations of darunavir, ritonavir and maraviroc at week 36 in CSF (compared to matched plasma samples calculated as plasma:CSF ratio) | — |
Countries
Spain, United Kingdom
Contacts
Public ContactGazzard
St Stephen's Aids Trust
Outcome results
None listed