Shionogi & GlaxoSmithKline ITG 20001 (S-1360): Antiviral therapy

A study to compare different doses of an integrase inhibitor versus placebo for its anti-HIV effectiveness, tolerability and safety.

Background
& Objective

 

Many people who are HIV+ and taking medications have strains of HIV that are resistant to most or all known antiretrovirals. All of the current anti-HIV drugs inhibit the activity of two of the HIV enzymes. Integrase inhibitors block the activity of a different HIV enzyme called “integrase”, which helps infected cells produce even more infectious virus. A completely different class of drugs, such as integrase inhibitors, could vastly increase the anti-HIV arsenal and prove especially helpful to those who do not respond to currently-available classes of medications.

 

 

 

 

Study Design

 

This is a new phase II trial to compare antiviral effect, safety, tolerability and pharmacokintetics (amount of drug in your blood) of four oral doses of S-1360 versus placebo. This 10-day study is for HIV infected volunteers who have never taken anti-HIV medications. It will involve two overnight stays at a local hotel (to be announced later), followed by a full day of timed blood specimen collections at our West Hollywood clinic. Volunteers will be compensated up to $875 for their inconvenience.

 

Inclusion
Criteria

 

This study is open to HIV+ adult men and women with no previous use of anti-HIV medications. Participants must have no current opportunistic infections. Viral loads must be between 400 to 50,000 copies/per mL, and T-cell counts must be 50 or above. Call the clinic (number below) for questions on specific inclusion criteria.

 


Status
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Enrolling
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Volunteers will be compensated up to $875 for their inconvenience.

For more information about participating in this study in the Los Angeles area, please call 310/358.2429 or e-mail Corie Castro at ccastro@aidsresearch.org

We encourage participation by women and people of color.

This ad was reviewed and approved by the AIDS ReSearch Alliance Institutional Review Board in September, 2002.

 


 

 

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