CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
standard care +1 moredrug
Likely dose
standard care 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01367236
NCT01367236Phase 4Completed
CompareCT.gov

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.

Imperial College London·interventional·Posted Jun 7, 2011·Updated Oct 21, 2019

In Brief

A Phase 4 clinical trial evaluating standard care and novel treatment for HIV and Impaired Cognition. Completed, enrolled 60 participants across 6 sites.

Detailed Summary

The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period. The study will compare anti-HIV therapy combinations which are currently in use. The patients will not have had any previous treatment for their HIV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Impaired Cognition
CountriesUnited Kingdom
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2011
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.1 years ago

Interventions

standard caredrug

* atazanavir 300 mg daily * ritonavir 100 mg daily * tenofovir 245 mg daily\* * emtricitabine 200 mg daily\*

novel treatmentdrug

* darunavir 800 mg daily * ritonavir 100 mg daily * lamivudine 300 mg daily\*\* and abacavir 600mgs daily\*\* * maraviroc 150 mg once daily