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START

Status
Completed
Phase
IV
Principal Investigator(s)
James D Neaton, PhD University of Minnesota - Clinical and Translational Science Institute
Objective

This study seeks to discover if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines. The START study also wants to learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

 

Prevention Option(s)
Treatment
Study Design
Controlled
Randomized
Arms and Assigned Interventions
Description
Initiate ART immediately following randomization.
Mode of Delivery
Tablet
ARMs
Experimental
Description
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops.
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Trial Sponsors
University of Minnesota - Clinical and Translational Science Institute
March 2009
July 2015
Enrollment
4 688
18
Years
Population
Women
Men
HIV positive
Sites

Site(s)-Argentina

Argentina

Site(s) - Australia

Australia

Site(s)-Austria

Austria

Site(s) - Belgium

Belgium

Site(s) - Brazil

Brazil

Site(s)-Chile

Chile

Site(s)-Czech Republic

Czech Republic

Site(s)-Denmark

Denmark

Site(s)-Estonia

Estonia

Site(s)-Finland

Finland

Site(s)-France

France

Site(s)-Germany

Germany

Site(s)-Greece

Greece

Site(s) - India

India

Site(s)-Ireland

Ireland

Site(s)-Israel

Israel

Site(s)-Italy

Italy

Site(s)-Luxembourg

Luxembourg

Site(s)-Malaysia

Malaysia

Site(s)-Mali

Mali

Site(s)-Mexico

Mexico

Site(s)-Morocco

Morocco

Site(s) - Nigeria

Nigeria

Site(s)-Norway

Norway

Site(s) - Peru

Peru

Site(s)-Poland

Poland

Site(s)-Portugal

Portugal

Site(s) - Puerto Rico

Puerto Rico

Site(s) - South Africa

South Africa

Site(s)-Spain

Spain

Site(s)- Sweden

Sweden

Site(s) - Switzerland

Switzerland

Site(s) - Thailand

Thailand

Site(s) - Uganda

Uganda

Site(s)- United Kingdom

United Kingdom