Studies enrolling at Baylor College of Medicine

Research studies at Baylor College of Medicine are an important part of developing better treatments and finding the cure for diseases. For a a list of studies and clinical trials at BCM, visit www.bcm.edu/clinicalstudies/. Some studies currently enrolling include:

Volunteers needed for HIV vaccine trial

Baylor College of Medicine is recruiting volunteers for a nationwide vaccine trial testing the safety and efficacy of a combination of two potential HIV vaccines and to see if they will stimulate an immune response to HIV.

"The HIV epidemic is still out of control. While HIV medications have improved the survival of people infected with HIV, developing methods to prevent or modify disease are badly needed to change the outlook of this epidemic," said Dr. Hana El Sahly, assistant professor of molecular virology and microbiology at BCM and principal investigator of the study.

The study is being conducted by the HIV Vaccine Trials Network and Baylor is one of 15 sites across the country participating in the trials. Neither of the vaccines can cause HIV infection.

Researchers are seeking HIV-uninfected (negative) men between 18 and 50 years of age who have sex with men or transgender women who have sex with men.

For more information, call 713-798-4912.

Postmenopausal women over 40 needed for dry eye study

Women over the age of 40 who are past menopause can take part in a research study evaluating omega-3 fatty acids or fish oil as a treatment for dry eye.

Dry eye is one of the most prevalent eye conditions in the United States, said Dr. Stephen Pflugfelder, professor of ophthalmology at Baylor College of Medicine and lead investigator of the BCM research site. Women who have passed menopause appear to have a predisposition for the condition, he said.

"Dietary intake of fish – especially tuna – has been proven to lower the incidence of dry eye in women," said Pflugfelder. "Omega-3 fatty acids have also been shown to improve dry eye symptoms."

Dry eye occurs when there is a lack of moisture or lubrication in the eye. Symptoms can include significant irritation, blurred vision and a great impact on quality of life, Pflugfelder said.

Working in a low humidity, draft environment or not eating enough fish or fish oil can contribute to the risk of this condition, Pflugfelder said.

Treatment can include over-the-counter artificial tears for mild conditions and custom-made contact lenses for the most severe conditions, Pflugfelder said.

To qualify, participants must:

• Be a woman 40 years or older who has passed menopause.
• Have dry eye symptoms.
• Be in generally good and stable overall health and on a stable medication routine.
• Not have had Lasik eye surgery within six months of taking part in the study.
• Not wear contact lenses.
• Not be involved in any other experimental drug or device studies.

Those who take part will visit the study clinic four times over a six-month period. The visits will include a screening visit and standard eye check-ups, tests and questionnaires.

For more information, please contact Margaret Olfson at molfson@bcm.edu or 713-798-8419.

Parkinson disease study now enrolling

Enrollment has begun in a new double-blind Phase 2b study evaluating CERE-120 in Parkinson's disease patients. Baylor College of Medicine is one of eight clinical sites enrolling along with 11 major medical centers across the country.

CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons in the hopes it will restore function and protect brain cells from further damage.

This study follows the Phase 1 portion that demonstrated early safety using an enhanced CERE-120 dosing regimen targeting two brain areas affected by Parkinson's disease.

The study is enrolling men and women between the ages of 35 and 70 who are diagnosed with idiopathic Parkinson's disease. They must be experiencing motor complications despite adequate antiparkinsonian therapy, as well as being on a stable, optimized regimen of antiparkinsonian medications and stable parkinsonian features for at least 6 weeks prior to screening. They must also be medically fit to undergo the study surgical procedure as determined by clinical and laboratory evaluations.

See the complete list of criteria that must be met to take part in the study.

For more information please call senior research coordinator Alicia Marie Palao at 713-798-3974 or e-mail palao@bcm.edu.

Ceregene, Inc., a biopharmaceutical company, is sponsoring the study, which is partially funded by a $2.5M LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) award from The Michael J. Fox Foundation for Parkinson's Research.