Clinical Trial of Brain-Penetrating HIV Drugs to Prevent Cognitive Impairment in China

NCT01340950 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-04-04

No results posted yet for this study

Summary

This primary aim of the project is to determine the association between antiretroviral therapy that better distributes into the central nervous system and prevention of HIV-associated neurocognitive impairment.

Conditions

Interventions

DRUG

zidovudine-lamivudine-nevirapine

96 weeks of zidovudine 300 mg orally twice daily, lamivudine 300 mg orally daily, nevirapine 200 mg orally daily for the first 14 days then 200 mg orally twice daily

DRUG

tenofovir-lamivudine-efavirenz

96 weeks of tenofovir disoproxil fumarate 300 mg orally daily, lamivudine 300 mg orally daily, efavirenz 600 mg orally daily

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • National Center for AIDS/STD Control and Prevention, China CDC

    collaborator OTHER_GOV
  • Beijing YouAn Hospital

    collaborator OTHER
  • Beijing Ditan Hospital

    collaborator OTHER
  • Peking University

    collaborator OTHER
  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Scott L Letendre, M.D. · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-07-31
Completion
2015-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340950 on ClinicalTrials.gov