CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 59 enrolled
Drug / intervention
FDA Approved Antiretroviral Therapy (see list below)drug
Likely dose
Not stated in 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/NCT00624195
NCT00624195Phase 3Completed
CompareCT.gov

HIV Neurocognitive Disorders: A Randomized Clinical Trial of CNS-Targeted HAART

University of California, San Diego·interventional·Posted Feb 27, 2008·Updated Apr 23, 2014

In Brief

A Phase 3 clinical trial evaluating FDA Approved Antiretroviral Therapy (see list below) for HIV Infections. Completed, enrolled 59 participants across 5 sites.

Detailed Summary

CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 27, 2008
Enrollment StartMar 1, 2007
Primary CompletionFeb 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.3 years ago

Interventions

FDA Approved Antiretroviral Therapy (see list below)drug

Combinations of FDA approved antiretroviral agents: Atripla, Combivir, Emtriva, Epivir, Epzicom, Retrovir, Trizivir, Truvada, Viread, Ziagen, Intelence, Rescriptor, Sustiva, Viramune, Agenerase, Aptivus, Invirase, Kaletra, Lexiva, Norvir, Prezista, Reyataz, Viracept, Fuzeon, Selzentry, Isentress Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir