An international group devoted to pediatric AIDS treatment is taking on a long-term global trial in hopes of replicating the success a University of Mississippi Medical Center researcher achieved in curing a baby born to an HIV-positive woman.
And although Dr. Hannah Gay, Mississippi’s leading pediatric AIDS specialist, won’t be directly involved, “I will be following it with great interest,” she said. “I’m certainly really excited about what’s going on.”
The new trial could further change the face of AIDS research on an international level and put more focus on helping babies in areas where they and their mothers have little access to health care.
Nature, an international weekly journal of science, reports on its website that the trial is being sponsored by the International Maternal Pediatric Adolescent AIDS Clinical Trials Group, or IMPAACT. The study would be conducted at 71 sites worldwide and involve the screening of hundreds of infants. The goal would be to find some 30 babies infected with HIV whose mothers weren’t treated for the virus during their pregnancy, the journal’s website reports.
Gay in March achieved international fame when she and two colleagues reported the first documented cure of a child infected with HIV, the virus that causes AIDS.
The Mississippi child had contracted HIV in the womb of her infected mother. Gay aggressively treated the girl with medication starting at 30 hours of life until she was about 18 months old. Then, both child and mother disappeared.
When Gay tracked them down five months later, the mother confessed she’d stopped giving her daughter medicine. Gay had expected the virus to come roaring back, but instead discovered the child appeared to be HIV-free. Several follow-up tests, as well as verification of previous tests, confirmed the cure.
“She’s doing great,” Gay said of the child, now almost 3. “We see her in the (UMMC) clinic every two months or so.”
Gay partnered with Dr. Deborah Persaud of Johns Hopkins University and Dr. Katherine Luzuriaga of the University of Massachusetts in the study and treatment of the Mississippi child. Persaud and Luzuriaga are members of the IMPAACT study group, Gay said, and Persaud serves as chair of IMPAACT’s Cure Committee.
Persaud and Luzuriaga both attended the International AIDS Society’s biennial meeting June 29 in Kuala Lumpur, Malaysia, Gay said.
“Deborah presented at the meeting the fact that this clinical trial will go forward,” Gay said. “They hope to enroll patients before the end of the year. It will be three to five years before we really know any results from it, but I’m certainly very excited that our case in Mississippi has kind of spurred this to go a little bit faster.”
During the IMPAACT trials, babies will be treated with a three-drug antiretroviral (ARV) mixture within 48 hours of birth. That’s similar to the drug regimen given to the baby treated by Gay. After a week, those babies will be retested, and those who test positive will receive a fourth ARV mixture.
During the three-year trial, the children will be tested for evidence of HIV antibodies in their blood, and to see if their immune systems are producing the antibodies. It’s hoped that the children who test negative for HIV won’t experience a recurrence when treatment is stopped.
“They’re going to screen them very carefully before taking them off their medicine,” Gay said. “What they will be able to do in their research labs is some ultra-sensitive testing that’s not available in commercial labs. They can test to see if there are viruses in hiding places. If there are, then they’re probably not going to be stopping the medicines. But, if they can test after three years and don’t find any, then they will be stopping the medicines to see what happens.”
Gay said she and fellow researchers hope the new trial will galvanize funding agencies to “look at the possibilities of being able to reduce further the number of infected infants in the world. It’s not going to happen overnight, but we’re certainly hopeful.”
Most of the IMPAACT study will take place outside the United States, Gay said. “We have so much good prevention of transmission here that we have very few transmissions from mother to infant.”
That’s why, she said, cases such as the baby she treated are so rare in the state.
“My goal is to make sure that we don’t have any more transmissions from mother to infant in Mississippi before I retire,” said Gay. “So, I really don’t want to be involved in these studies here, because I don’t want to have any babies infected in Mississippi.”