Isentress is a go!
Last month, Positively Aware reported that approval of the first HIV drug from an...

Aptivus granted traditional FDA approval
Traditional FDA approval was granted earlier this month to Aptivus (tipranavir), another...

Plans for the use of needle-free device with Fuzeon foiled
Earlier this month, Roche and Trimeris, Inc., makers of the first and only injectable anti-HIV...

TPAN awarded $2.5 million SAMHSA grant
Test Positive Aware Network, the parent organization to Positively Aware, was recently...

HIV studies in Kansas City
Kansas City University of Medicine and Biosciences’ Dybedal Clinical Research Center...

Isentress is a go!

Last month, Positively Aware reported that approval of the first HIV drug from an entirely new class of drugs known as integrase inhibitors, raltegravir, had been recommended for approval by a panel of medical experts brought together by the U.S. Food and Drug Administration (FDA).

Last week, it was announced that raltegravir (brand named Isentress by its creator Merck) was granted accelerated approval by the FDA.

Accelerated approval was granted based on data from clinical studies involving treatment-experienced individuals who had previously been on one or more HIV regimens with documented resistance to at least one drug in three currently available classes of HIV drugs (NRTI’s, NNRTI’s, and PI’s).

When used with other HIV medicines, these studies showed that raltegravir may significantly reduce the amount of HIV in the blood and may increase CD4+ T-cells (T-cells), which help fight other infections.

The long-term effects of raltegravir are not known at this time, and its safety and effectiveness in pregnant women and children less than 16 years of age has not been studied.

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Aptivus granted traditional FDA approval

Traditional FDA approval was granted earlier this month to Aptivus (tipranavir), another anti-HIV medication from a drug class known as protease inhibitors (PIs).

Aptivus has proven to be effective at combating HIV in people who are treatment-experienced (already taken one or more HIV drug regimens) and whose HIV has developed resistance to more than one protease inhibitor. This development offers continued hope for the thousands of people living with HIV/AIDS who currently have limited treatment options available to them as a result of resistant virus.

Accelerated approval of the drug was granted in June of 2005, based on data from two controlled phase 3 trials of Norvir-boosted Aptivus at 24 weeks. The traditional approval is based on data from the same trials at 48 weeks and beyond, confirming the durability of HIV viral suppression.

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TPAN awarded $2.5 million SAMHSA grant

Test Positive Aware Network, the parent organization to Positively Aware, was recently awarded a $2.5 million grant from the U.S. Department of Health and Human Services’ Substance Abuse Mental Health Services Administration (SAMHSA).

Under the provisions of the five-year grant, TPAN will initiate a program known as POWER (Positive Outcomes for Wellness, Education and Recovery). POWER is a holistic health recovery program that provides sexual, drug, and alcohol education and intervention, as well as group and individual counseling to African American men, both HIV-positive and negative, who engage in high-risk behaviors.

The program is in partnership with Heartland Alliance, a service-based human rights organization in Chicago. Heartland will provide intensive outpatient and residential treatment services for the program.

“We are proud to add this innovative program to our portfolio of unique, peer-led services,” said Rick Bejlovec, executive director of TPAN. Planning for POWER is underway, with a launch date projected for early 2008.

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HIV studies in Kansas City

Kansas City University of Medicine and Biosciences’ Dybedal Clinical Research Center is currently enrolling participants for two clinical research studies for the treatment of HIV.

SPRING Study – Designed to demonstrate the safety and efficacy of Norvir-boosted Aptivus (tipranavir) among racially diverse men and women who are HIV-positive and three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one protease inhibitor.

To qualify you must:

• Be HIV-positive
• Be at least 18 years old
• CD4 count greater than 50
• Viral load greater than 1000
• Be treatment experienced
• Be available for 11 out-patient visits during the 60-week trial

If you qualify, you will receive:

• Reimbursement for HIV medications, as well as time and travel
• Medical examinations and laboratory testing at no cost

KP-1461 Study (see Positively Aware September/October 2007)

To qualify you must:

• Be HIV-positive
• Be treatment experienced
• Be off antiretroviral therapy for four months
• Be 18-65 years of age
• Have a viral load greater than 2500
• CD4 greater than 250
• Be available for 17 visits over a 30-week period

If you qualify, you will receive:

• Experimental study-related medications and exams at no cost
• Reimbursement for time and travel

For more information or to see if you qualify, e-mail crc@kcumb.edu or call (816) 283-2335 or (800) 234-4847 and ask for the research center.

If you are interested in these studies and live outside of the Kansas City area, visit www.clinicaltrials.gov for more information.

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