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Experimental HIV Drugs

Shionogi-GlaxoSmithKline Pharmaceuticals Will Revise Inclusion Criteria for a Clinical Study of the Experimental Integrase Inhibitor S/GSK1349572 To Incorporate Concerns of HIV Treatment Advocates

Shionogi-GlaxoSmithKline is developing S/GSK1349572, an experimental HIV integrase inhibitor, for use as a first-line treatment in HIV patients. Following discussions with two AIDS treatment advocacy groups, the European AIDS Treatment Group and the AIDS Treatment Activists Coalition, the companies agreed to revise inclusion criteria for a dose-ranging study of the drug in HIV patients without prior antiretroviral treatment. The revision will raise the minimum allowable CD4+ count for entry to the study to 200 cells/mm3 or higher. The advocacy groups argued that HIV patients with CD4+ counts below 200 cells/mm3 should only be treated with FDA-approved standard of care therapies.

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A Review of the Experimental NNRTI Rilpivirine

This review of the experimental NNRTI rilpivirine summarizes studies demonstrating that the drug has potent activity against HIV, including against NNRTI-resistant strains of the virus. After 96 weeks of treatment, rates of HIV suppression in treatment-naive patients compared favorably with those of efavirenz (Sustiva). The safety profile of rilpivirine was also favorable, with fewer central nervous system disturbances compared with efavirenz and, thus far, no concerns about its use during pregnancy.

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New Analysis Shows Novel Nucleoside Analog KP-1461 Demonstrates Clinical Activity against HIV

KP-1461 is an investigational nucleoside analog that works differently than approved nucleoside/nucleotide reverse transcriptase inhibitors. With its unique mechanism of action, the agent accelerates HIV mutation to such an extent that the virus is disabled -- a phenomenon known as "terminal mutagenesis" or "error catastrophe."

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Safety Monitoring Board Says Phase 3 Trial of Experimental NRTI Apricitabine Can Go Forward Using Lower Dose

A Data and Safety Monitoring Board (DSMB) has approved the continuation of a Phase 3 clinical trial of the experimental nucleoside reverse transcriptase inhibitor (NRTI) apricitabine, according to Avexa Limited, the company developing the drug.

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Gilead Initiates Phase 2 Clinical Trial of Once-daily, Single-tablet, 4-drug Combination Pill Containing Integrase Inhibitor Elvitegravir

Gilead Sciences announced on April 17, 2009 that the company has initiated a Phase 2 clinical trial to assess the safety and efficacy of the new "QUAD" 4-drug combination pill containing elvitegravir, GS 9350, and emtricitabine/tenofovir (the drugs in the Truvada pill) versus the 3-drug efavirenz/tenofivir/emtricitabine (Atripla) combination pill in treatment-naive HIV positive adults.

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