ACTG 5202 PDF

There was also no significant difference in time to failure between efavirenz and ritonavir-boosted atazanavir, when paired with either of the two dual-nucleoside backbones. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective. Comparing one group with another, expresses differences in the risk of something happening. A hazard ratio above 1 means the risk is higher in the group of interest; a hazard ratio below 1 means the risk is lower.

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There was also no significant difference in time to failure between efavirenz and ritonavir-boosted atazanavir, when paired with either of the two dual-nucleoside backbones. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels.

Without the boosting agent, the prescribed dose of the primary drug would be ineffective. Comparing one group with another, expresses differences in the risk of something happening. A hazard ratio above 1 means the risk is higher in the group of interest; a hazard ratio below 1 means the risk is lower. Expresses the risk that, during one very short moment in time, a person will experience an event, given that they have not already done so.

Any member of a group of substances containing both lipid fat and protein. Lipoproteins are found in both blood plasma and cell membranes. They are the mode of transport for cholesterol through the bloodstream and lymphatic fluid.

ACTG was a blinded clinical trial in which treatment-naive patients were randomised to begin one of four different antiretroviral combinations.

The study design therefore included four different major comparisons, one for each permutation of study drugs:. Participants in the high viral load stratum were unblinded — i. Data from this point in the study comparisons of the two nucleoside combinations for patients with high viral loads , have been presented and widely circulated. There were also no significant differences in time to failure between efavirenz and boosted atazanavir, in combination with either of the pairs of nucleosides.

See, however, the discussion of equivalence, below. There were some significant differences in time to adverse events and regimen changes. Eric Daar noted that many of these were abacavir hypersensitivity reactions [HSR], as HLA screening was not in standard practice at the time. A post-hoc analysis, which could retrospectively exclude patients with HSR, has not yet been done. Although no significant difference appeared in any of the paired comparisons between treatment combinations, ACTG was not able to formally demonstrate "equivalence" for any comparison.

This is due to somewhat involved statistical considerations. In the first place, an equivalence comparison is more stringent than the "non-inferiority" comparison commonly used in antiretroviral clinical trials. Secondly, the difference between anticipated and actual study outcomes made the definition of equivalence more demanding than originally intended.

In fact, the actual number of failures was considerably smaller, with the statistical effect of making equivalence a more stringent condition. In short, although the paired efficacy comparisons fell short of formal equivalence as defined in the study protocol, they still demonstrated a lack of statistically significant difference in outcomes.

You can view the abstract on the official conference website. You can also view a webcast and slides of this session on the official conference website.

Daar E et al. Starting treatment. Primary tabs View active tab Preview. Derek Thaczuk. This article is more than 10 years old. Click here for more recent articles on this topic. Find out more in our About HIV pages. More news from CROI Related topics.

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You have reached the HIVandHepatitis. Please visit our new site at hivandhepatitis. A total of treatment-naive participants enrolled during were randomly assigned to receive one of 4 combination regimens:. The high viral load group was therefore unblinded and offered the chance to switch therapy. The study continued with the low viral load group. Participants were followed through September , or 96 weeks after the last patient enrolled median weeks of follow-up. The overall number of virological failures was lower than expected, and the study did not meet its protocol endpoint of proving "equivalence.

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ACTG 5202 -- Effectiveness of Different Treatments

There are several potential choices when it comes to the initial treatment of HIV infection. Is atazanavir-ritonavir equivalent to efavirenz when used in combination with either Kivexa or Truvada? In January , an interim analysis found that participants who entered ACTG with a high viral load more than , copies and who also received Kivexa were at increased risk for treatment failure. The Data Safety Monitoring Board DSMB overseeing the study recommended that the nuke portions of the study be unblinded and participants then had the option of continuing to take their assigned nukes or changing them.

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Early virologic response to abacavir/lamivudine and tenofovir/emtricitabine during ACTG A5202

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