STATEMENT
NIAID Modifies Trial Involving Antiretroviral Therapy in HIV-infected Infants
On June 20, 2007, an independent Data and Safety Monitoring Board (DSMB) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met to review interim data on safety and efficacy from a clinical trial examining strategies for treating HIV-infected infants under 3 months of age, including the optimal time to begin antiretroviral (ARV) therapy. The NIAID-sponsored “Children with HIV Early Antiretroviral Therapy” (CHER) study, which began enrollment in July 2005, is being conducted at two locations in South Africa. It is coordinated by an international team from the Perinatal HIV Research Unit in Johannesburg, South Africa; the Children’s Infectious Diseases Clinical Research Unit in Cape Town, South Africa; the Medical Research Council Clinical Trials Unit in London and NIAID’s Division of AIDS.
The DSMB reviewed the interim data and found a significant increase in survival among infants who received immediate ARV therapy (96 percent) compared to infants who received therapy later (84 percent) based on declining immune function linked to a defined CD4+ T-cell count and/or clinical progression, which is the current World Health Organization standard of care in South Africa and other parts of the world. The actual immunologic and clinical criteria for starting ARV therapy in the study have changed over time to reflect changing standards of care.
Based on this finding, the DSMB recommended that no additional infants be placed in the deferred-treatment arm of the study and infants in this arm be evaluated for potential initiation of ARV therapy. The DSMB also recommended that all infants enrolled in the study be followed for the planned duration of approximately 3.5 years. NIAID Director Anthony S. Fauci, M.D., concurred with the DSMB recommendations.
The study investigators at each site have been informed of the DSMB decision and are contacting the parents and legal guardians of the infants involved in the study to inform them of the interim findings and the changes to the study. Information comparing results in the two immediate arms combined with those in the deferred-treatment arm is also being released to local ethics committees, regulatory authorities and other key stakeholders.
Findings from this study will be presented on Wednesday, July 25 at the 2007 International AIDS Society Conference in Sydney, Australia.
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov
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