when were the short course azt trials

How did the short-course AZT trials differ from the Tuskegee Study?

The “short course” AZT Trials 1994, a study conducted by the AIDS Clinical Trials Group demonstrated the effectiveness of the antiretroviral drug zidovudine (AZT) in preventing mother- to-child transmission of HIV. The complex “076 regimen,” which started administering AZT in the second trimester of pregnancy and continued through to treatment of the infant. Reduced HIV …

Are short-course AZT trials for HIV treatment effective?

Jan 29, 2011 · But it took a careful review of the AZT trial to make me understand just how much we were able to do. The clinical trial on which AZT’s approval was based had produced a dramatic result. Before the planned 24 week duration of the study, after a mean period of participation of about 120 days, nineteen participants receiving placebo had died ...

What happened in the AZT trial?

This last justification was articulated for PCTs of “short course” AZT for the prevention of mother to child HIV transmission in developing countries in the late 1990s. An intervention proven effective in the U.S. for reducing perinatal transmission using Zidovudine (AZT), the “076 regimen,” had become the standard of care in developed countries.

What is the difference between the AZT and other studies?

Oct 23, 2006 · In 1994, the results of the AIDS Clinical Trial Group (ACTG) 076 study demonstrated that a long course of AZT prevented mother to child transmission of HIV. Concerned that the ACTG 076 regimen could not be implemented in resource poor settings, researchers subsequently began clinical trials of short course AZT in Uganda, South Africa, …

What is the short course AZT trials?

PIP: The ACTG 076 trial assessed the ability of zidovudine (AZT) to prevent the transmission of HIV from mother to child. In that trial, women received 100 mg of AZT 5 times daily beginning from 14-34 gestational weeks, then intravenous AZT during labor.

Do you think the short course AZT trials were ethical give reasons why or why not?

These trials were criticized as unethical because researchers did not provide all of the participants AZT; some women were randomized to placebos. This study seeks to account for the emergence, legitimation, and resolution of these trials as a social problem.

Clinical Question

Among patients with HIV/AIDS, does therapy with zidovudine reduce mortality when compared to placebo?

Bottom Line

Zidovudine reduces mortality in patients with HIV/AIDS when compared to placebo in this trial with an average follow-up of 4 months.

Major Points

Given the high mortality with HIV/AIDS and lack of an effective therapy, much effort went into identifying a potentially effective antiretroviral therapy in the 1980s. The nucleoside analog reverse transcriptase inhibitor (NRTI) zidovudine (ZDV; formerly azidothymidine or AZT) halts HIV replication through termination of viral DNA-chain elongation.

Funding

Not explicitly stated though the zidovudine patent was held by the Burroughs Wellcome Company (which was subsequently purchased by GlaskoSmithKline, which joined with Pfizer to become ViiV Healthcare) participated and presumably helped fund the trial. Zidovudine was subsequently sold under the trade name Retrovir by these groups.

Clinical Question

• Among patients with HIV/AIDS, does therapy with zidovudine reduce mortality when compared to placebo?

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Bottom Line

Major Points

Guidelines

Design

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Funding

Further Reading