A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells

NCT01173510 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-06-14

No results posted yet for this study

Summary

Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing integration of Human Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who have never taken antiretroviral medications, this research study will test whether Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus (HIV)from key immune system cells.

Conditions

  • HIV Infections
  • Acquired Immune Deficiency Syndrome

Interventions

DRUG

Raltegravir plus Truvada

Raltegravir 400 mg twice daily plus tenofovir/emtricitabine (Truvada) one tablet once daily

DRUG

Atripla

Efavirenz/Emtricitabine/Tenofovir DF one tablet once daily

Sponsors & Collaborators

Principal Investigators

  • Clyde S Crumpacker, MD · Beth Israel Deaconess Medical Center - Division of Infectious Disease

  • Calvin J Cohen, MD · Community Research Initiative of New England

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-23
Primary Completion
2012-10-19
Completion
2012-10-19

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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 NCT01173510 on ClinicalTrials.gov