EUCTR2011-002656-14-GBActive, not recruitingPhase 1
A randomised, prospective study, assessing changes in cerebral function in treatment naive HIV-1 infected subjects commencing either boosted atazanavir with Truvada or boosted darunavir with maraviroc and Kivexa - CogUK
Imperial College0 sites60 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •HIV-1 infected males or females • signed informed consent • no previous antiretroviral treatment since HIV diagnosis • screening CD4+ lymphocyte count <= 350 cells/uL • susceptible to all currently licensed NRTIs, NNRTIs and PIs based on HIV-1 genotypic resistance report
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •Existing neurological disease • Hepatitis B or hepatitis C co-infection • Age under 18 years • Screening laboratory parameters > grade 2 (with the exception of cholesterol and triglycerides) • Current history of major depression or psychosis • Recent head injury (past three months) • Current alcohol abuse or drug dependence • Active opportunistic infection or significant co-morbidities • Patients who are receiving other concomitant medication which are not permitted, as listed in appendix 2 of the protocol • Female patients of child-bearing potential who: have a positive pregnancy test at screening or during the study are breast feeding are planning to become pregnant all participants unwilling to use a barrier method of contraception and a second form of contraception. The use of the combined contraceptive pill is unacceptable as its efficacy may be impaired by the study drugs. The progesterone only pill is acceptable. • Patients who in the opinion of the investigator are not candidates for inclusion in the study • cardiovascular risk calculation, in the opinion of the investigator, not acceptable to commence study medication Tropism testing Genotypic tropism testing will be undertaken at screening. Subjects who are non-CCR5 tropic will be allowed to enter study as optimal antiretroviral activity will still be achieved within ARM 2 from the activity of boosted darunavir with abacavir and lamivudine.
Investigators
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