Phase 4
N=60
Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
HIV · Impaired Cognition
Bottom Line
View on ClinicalTrials.gov: NCT01367236 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Cognitive Function, Global Cognitive Score (Z-score) — 0.15; 0.19; 0.16; 0.25 z score — p=0.68
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- standard care (Drug); novel treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Function, Global Cognitive Score (Z-score) |
0.15; 0.19; 0.16; 0.25 | 0.68 |
| SECONDARY Brain Function, Absolute Change Over 48 Weeks of N-acetyl Aspartate/Creatinine Ratio |
0.071; -0.097 | 0.0009 sig |
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.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected males or females
- signed informed consent
- no previous antiretroviral treatment since HIV diagnosis
- screening CD4+ lymphocyte count 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
- female patients of child-bearing potential who:
- have a positive serum 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
- patients who in the opinion of the investigator are not candidates for inclusion in the study
Data sourced from ClinicalTrials.gov (NCT01367236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.