Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
 |
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes Of Health (NIH) - March 6, 2008
On February 28, NIAID announced that it modified an HIV antiretroviral treatment study in HIV-infected participants who had never taken anti-HIV drugs. The study, known as ACTG 5202, was modified because one of the four drug regimens (abacavir/lamivudine) under investigation was not as effective at controlling the virus in participants with initially high levels of virus. Further, participants with higher viral loads experienced a shorter duration of time to experiencing non-specific side effects, such as body aches and elevated cholesterol levels. The modifications were based upon the recommendations of an independent Data and Safety Monitoring Board.
Those participants with high viral loads at time of screening who were on the affected treatment regimen are being counseled and offered the opportunity to switch to another treatment regimen, if appropriate. Those participants with low levels of HIV virus who were on the abacavir/lamivudine regimen will remain on their established regimen. The remainder of the study is continuing as planned.
For more information, please see the NIAID Bulletin below. Please feel free to share this bulletin with your organization and its constituents. Here is the URL: http://www3.niaid.nih.gov/news/newsreleases/2008/actg5202bulletin.htm
NIAID Modifies HIV Antiretroviral Treatment Study: Combination Therapy that Includes ABC/3TC Found Less Effective in Subgroup of Antiretroviral-Naïve Individuals
An independent Data and Safety Monitoring Board (DSMB) met recently to review data from a clinical trial examining the safety, tolerability and effectiveness of four different antiretroviral treatment regimens in HIV-infected adults who had never taken anti-HIV drugs before. The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, involves a randomized comparison of the HIV drug efavirenz (EFV) with atazanavir boosted with ritonavir (ATV/r), and a double-blind, randomized comparison of co-formulations of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) with abacavir/lamivudine (ABC/3TC). The DSMB has recommended changes to the study on the basis of new findings in a subset of participants who have been receiving ABC/3TC.
This study is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG) and is known as ACTG 5202. The trial is important for examining initial HIV treatment regimens because existing regimens may vary both in their ability to suppress the level of HIV in the blood (viral load) and in the side effects with which they may be associated.
Investigators enrolled 1,858 eligible men and women into the Phase III efficacy study between September 2005 and November 2007 at 64 sites in the United States. Participants were divided into two groups based on HIV levels at the time of screening: those with high viral loads (100,000 or more copies of HIV RNA per milliliter of blood) and those with lower viral loads (fewer than 100,000 copies/mL). Each volunteer was assigned at random to one of the four treatment groups:
All regimens effectively reduced the amount of virus in most participants. However, the DSMB found that among participants with high viral loads at the time of screening, treatment combinations that included ABC/3TC were not as effective in controlling the virus as those on regimens containing FTC/TDF. This was the DSMB's primary concern. Secondarily, the DSMB found that among participants with a high viral load at screening, those receiving ABC/3TC experienced a shorter time to developing non-specific side effects, such as body aches, and laboratory test abnormalities, such as elevated cholesterol and triglyceride levels, than those receiving FTC/TDF. In general, these side effects were obvious to participants or the study physicians and would have been readily managed or treated.
The DSMB had no safety concerns regarding EFV or ATV/r and recommended that study participants in the lower viral load group who were taking ABC/3TC should continue with their assigned treatment regimen.
Based on its findings, the DSMB recommended that all participants who had high viral loads at screening be told which treatment regimen they are receiving and stop taking their placebo pill. The DSMB also recommended that those participants receiving ABC/3TC who had high viral loads at screening be counseled on what the DSMB findings might mean for them and possibly be shifted to another regimen, if appropriate. Finally, the DSMB recommended that the remainder of the study continue as originally designed. NIAID concurred with the DSMB's recommendations.
ACTG has notified the site investigators and the affected study participants of the DSMB's recommendations. In consultation with the site study teams and their physicians, these participants may continue taking ABC/3TC, switch to FTC/TDF or switch to alternative antiretroviral combinations.
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.
080306
NI080301
Published 2008 - National Institute of Allergy and Infectious Diseases . All material contained in this report is in the public domain and may be used and reprinted without special permission; citation to source, however, is appreciated.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2008. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2008. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .