AIDSWEEKLY Plus; Monday, September 10, 2001
Michael Greer, Staff Medical Writer

NewsRx - Researchers in California say that an antiretroviral regimen consisting of four medications taken once a day can provide safe and effective control of HIV infection.

Larry Mole and colleagues at the Veteran's Affairs Palo Alto Health Care System and at Stanford University conducted a study to "evaluate the tolerance, pharmacokinetics, and virologic and immunologic outcomes of once-daily indinavir, ritonavir, didanosine, and lamivudine in HIV seropositive individuals."

The regimen studied provided excellent viral control and immunologic restitution with minimal toxicity in their preliminary study, Mole and coauthors reported.

The 10 study participants, all of whom had no or minimal exposure to antiretroviral drugs, were given 400 mg of didanosine before a meal followed by 1200 mg of indinavir, 400 mg of ritonavir, and 300 mg of lamivudine during that meal. All patients had undetectable viral loads after 28 weeks, the researchers said, with eight patients achieving undetectable viral loads after 12 weeks of treatment. Moreover, the median CD4 count in these patients rose by 193 cells/mm³ after 24 weeks.

For the most part, adverse side effects related to treatment were mild, according to the report. However, median triglyceride levels rose by 109% by the 24th week of treatment, and median nonfasting cholesterol levels rose by 49% over this time.

Two of the 10 study participants had plasma ritonavir levels below the effective concentration (EC50) for that drug, and four patients had indinavir levels lower than the inhibitory concentration (IC95) ("A pilot trial of indinavir, ritonavir, didanosine, and lamivudine in a once-daily four-drug regimen for HIV infection," J Acquir Immune Defic Syndr 2001 Jul 1;27(3):260-265.

"Our pilot study demonstrates excellent virologic suppression despite low minimum protease inhibitor concentrations during a dosing interval in some patients and is supportive of further study," Mole and colleagues concluded.

The corresponding author for this report is Larry Mole, Veteran's Affairs Palo Alto Health Care System, Center for AIDS Research, 3801 Miranda Avenue 132, Palo Alto, CA 94304 USA.

A search at www.NewsRx.net using the search term "AIDS and HIV therapy" yielded 1,191 articles in six specialized reports.

Key points reported in this study include:

• An antiretroviral regimen consisting of four drugs (indinavir, ritonavir, didanosine, and lamivudine) taken once per day has shown positive results in a preliminary study
  


• The 10 study participants, who had no or minimal exposure to antiretroviral drugs, all had undetectable viral loads and markedly improved immune cell counts after 28 weeks
  


• Toxicity was mild although lipid levels were elevated
  

This article was prepared by AIDS Weekly editors from staff and other reports.

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