Strategic Timing of Antiretroviral Treatment

Summary

Objectives:

* To find out 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.
* 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.

Conditions

• HIV Infection

Interventions

DRUG

All licensed antiretroviral medications

In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark

  collaborator UNKNOWN

• Medical Research Council

  collaborator OTHER_GOV

• Kirby Institute

  collaborator OTHER_GOV

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• ANRS, Emerging Infectious Diseases

  collaborator OTHER_GOV

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• NEAT - European AIDS Treatment Network

  collaborator OTHER

• National Health and Medical Research Council, Australia

  collaborator OTHER

• National Institutes of Health Clinical Center (CC)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• Abbott

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Gilead Sciences

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Tibotec Pharmaceutical Limited

  collaborator INDUSTRY

• University of Minnesota

  lead OTHER

Principal Investigators

• James D Neaton, PhD · University of Minnesota

• Abdel Babiker, PhD · Medical Research Council Clinical Trials Unit, London

• Jens Lundgren, MD, DMSc · Copenhagen HIV Programme

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-15

Primary Completion

2022-07-27

Completion

2022-07-27

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Chile
• Czechia
• Denmark
• Estonia
• Finland
• France
• Germany
• Greece
• India
• Ireland
• Israel
• Italy
• Luxembourg
• Malaysia
• Mali
• Mexico
• Morocco
• Nigeria
• Norway
• Peru
• Poland
• Portugal
• Puerto Rico
• South Africa
• Spain
• Sweden
• Switzerland
• Thailand
• Uganda
• United Kingdom

Study Locations