Merck and HVTN discontinue vaccination and enrollment in studies of an HIV vaccine
In mid-September, Merck and Co. Inc. and the HIV Vaccine Trials Network (HVTN)...

FDA approves upgrade in pregnancy category for Viramune
Viramune, an anti-HIV medication from a class of drugs known as non-nucleoside...

Superstar comedian and actress Mo’Nique keeps her commitment to fighting HIV in the Black community
Following a sold out performance at the 7th Annual Pride Comedy Night in September...

Prescription Drug User Fee Act reauthorized with provisions to improve drug safety
In late September, President Bush approved legislation to reauthorize the Prescription...

Merck and HVTN discontinue vaccination and enrollment in studies of an HIV vaccine

In mid-September, Merck and Co. Inc. and the HIV Vaccine Trials Network (HVTN) announced that vaccination in a phase 2 study of Merck’s experimental HIV vaccine is being discontinued. A scheduled interim efficacy analysis of the study found it to be ineffective at preventing new HIV infection and at reducing the amount of virus in those who became infected.

The trial, known as STEP, was an international “test of concept” trial involving 3,000 uninfected volunteers in Australia, the Americas and the Caribbean  who are at high risk for acquiring HIV. Enrollment and vaccination in another phase 2 study of the vaccine that was being conducted in South Africa, known as Phambili, and two additional phase 1 trials have also been discontinued.

“This is a huge disappointment for all of us who have been involved in the search for an HIV vaccine,” said Glenda Gray, M.D., principal investigator of the HVTN-sponsored Phambili trial. “HIV is ravaging our communities, and all the scientists, participants and communities involved in HIV vaccine studies have been affected by this epidemic. The scientific community must continue the race to find a vaccine to help secure an HIV-free generation for the future.”

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FDA approves upgrade in pregnancy category for Viramune

Viramune, an anti-HIV medication from a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTI’s), was recently upgraded to be included in pregnancy Category B from Category C – making it the only NNRTI to achieve such status. Viramune is also the only NNRTI recommended by the U.S. Department of Health and Human Services for use in pregnant women.

Pregnancy category is one of many treatment considerations for discussion by HIV-positive women and their health care providers. Category titles range from Category A-D and Category X, with drugs in Category A considered to be the safest for pregnant women, and those in Category X considered to be completely dangerous and not recommended at all.

It is important to note, however, that life-threatening and fatal liver toxicity has occurred in patients taking Viramune, and that the drug is not recommended for women with CD4 counts with greater than 250 cells – the group considered to be at greatest risk for such toxicity. Therefore, it is still recommended that Viramune be used in this group only if the potential risk justify the potential.

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Superstar comedian and actress Mo’Nique keeps her commitment to fighting HIV in the Black community

Following a sold out performance at the 7th Annual Pride Comedy Night in September, superstar comedian and actress Mo’Nique participated in a lively community discussion held at Chicago State University – home of the Illinois HIV/AIDS Research and Policy Institute.

“I’m sitting back watching my brothers and sisters die (of HIV and AIDS), and that’s no fun,” Mo’nique said to the crowd through tears. “We have to stop waiting on the government to come and save us. When have they ever stepped in to save Black people?”

Pride Comedy Night is an annual event put on by Madman Productions, a Chicago-based event planning and promotion company, to raise money for community-based organizations that offer HIV prevention and treatment services to African Americans. The Luck Care Center, headed by Dr. William Johnson and his wife Bethsheba (who is also a nurse practitioner), was the sole beneficiary of this year’s show, which also featured a spoken word performance by Positively Aware associate editor Keith Green.

Mo’Nique, who lost her best friend Charisse to AIDS in 2002, has been involved with the event since its inception. The forum, which was a new addition this year, featured representation from several community based organizations including the South Side Help Center, Project Vida, and Test Positive Aware Network.

Things got a little tense when Mo’Nique called out a young woman in the crowd for pointing and snickering at a transgender woman on the panel.

“If I don’t say something about this now, I will be messed up for it later,” she said in a tone that brought the entire room to silence. “How dare you sit there and do that while we’re having a conversation like this? And you’re sitting there holding a baby! What if that baby grows up and realizes that he or she is not the person that you think he or she is? How will you respond to that? Will you point and snicker at him or her?”

The confrontation ended with the young woman coming on stage to apologize for her actions and to shake hands and hug the transgender woman whom she offended.

“We have got to stop the hatred, ya’ll,” Mo’Nique said to the crowd. “It is the biggest disease of all.

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Prescription Drug User Fee Act reauthorized with provisions to improve drug safety

In late September, President Bush approved legislation to reauthorize the Prescription Drug User Fee Act (PDUFA). Under the revised law, the fee that pharmaceutical companies pay the Food and Drug Administration (FDA) to reduce the time it takes to approve new medications will increase by about 25%, bringing the total amount paid in fees to nearly $400 million each year.

“The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems,” said Bill Tauzin, president of the Pharmaceutical Research and Manufacturers of America to the Associated Press.

In addition, according to the Kaiser Daily Health Policy Report issued on September 21st, the bill includes provisions that address prescription drug safety, post-market studies on new medications, prescription drug advertisements, clinical trial disclosures, pediatric trials, and conflicts of interest.

“The FDA safety legislation has been a long time coming,” said Lynda Dee, Executive Director of AIDS Action Baltimore and member of ATAC (AIDS Treatment Activist Coalition). “Our coalition of national disease organizations, Alliance for Drug Safety and Access (ADSA), has been working with the Senate HELP Committee on this since June of 2005.”

“We hope this will mean that drugs will be safer because the FDA will have more authority over drug companies to require post-marketing studies and label changes, and that more information about clinical trails will be available both while trials are recruiting and after they are completed.”

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