Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
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Reuters NewMedia - Tuesday October 26, 1999
In a randomized, double blind study of 162 HIV-infected patients who had not been previously treated, 83 percent of those that were given Coactinon, along with the two other drugs, had undetectable levels of the virus after 24 weeks. This was significantly better than the comparison group, which was given a placebo plus the two other drugs. Forty percent of the comparison group showed undetectable levels of the virus after 24 weeks, a company spokesman told Reuters.
The two other drugs in the cocktail, d4T (stavudine) and 3TC (lamivudine), are called nucleoside reverse transcriptase inhibitors.
Reverse transcriptase is an enzyme found on the surface of the HIV virus, which helps it reproduce. d4T and 3TC inhibit the action of the enzyme and are thus called reverse transcriptase inhibitors.
There are two types of reverse transcriptase -- nucleoside and non-nucleoside. Coactinon, which was used with two nucleoside reverse transcriptase inhibitors in this study, functions as a non-nucleoside reverse transcriptase inhibitor. Triangle said that Coactinon was generally well tolerated, but there were "mild to moderate" adverse events, which occurred early in treatment.
The most frequent adverse events included nausea, headache, dizziness, diarrhea, and rash.
The regimen was protease inhibitor-sparing, which means the drug cocktail did not include a protease inhibitor, a drug commonly used in anti-HIV cocktails. Protease is another enzyme associated with the HIV virus.
Triangle noted that this is one of the pivotal Phase II/III trials it is conducting with Coactinon and the first of several studies utilizing protease inhibitor-sparing regimens.
These data will be used to support the New Drug Application for Coactinon that Triangle plans to file with the U.S. Food and Drug Administration. The present study continued through 48 weeks. The 48 weeks just ended and the data is being analyzed.
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