Efavirenz to Rilpivirine FDC Switch Study
- Conditions
- HIVTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-002205-22-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
- 40
- Is male or female aged 18 years or above
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Has been on Atripla for at least 12 weeks OR Kivexa plus efavirenz
- Has an HIV-plasma viral load at screening <50 copies/mL (single re-test allowed)
- Has a CD4 cell count at screening >50 cells/mm3
- Estimated glomerular filtration rate (MDRD) >50 ml/min.
- Has symptomatic CNS related toxicity associated with EFV
- If female and of childbearing potential, 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. 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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs (note acid-reducing agents and interaction with rilpivirine)
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN
Note: Subjects can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
- Any investigational drug within 30 days prior to the trial drug administration
- Has received rilpivirine in the past
- Any clinical evidence of baseline resistance mutations
- Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- Severe hepatic impairment
- Moderate or severe renal impairment (creatinine clearance < 50ml/min)
- If female, she is pregnant or breastfeeding
- Screening blood result 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).
- 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