A study to learn how diffent drugs used in the treatment of HIV may influence brain function in patients who are HIV positive and who have not had any previous treatment for this condition.

Phase 1

• Conditions: HIV infection and cognitive function; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002656-14-GB
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-01
• Study Completion: 2015-10-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified