SMART

They call it SMART and it launches on Monday, October 15, 2001. SMART stands for Strategies for the Management of Anti-Retroviral Therapy, and it will be the largest, most ambitious clinical trial in the history of the HIV/AIDS epidemic. The study will involve 6,000 patients and last for as long as eight years.

Driven by the widespread recognition that anti-HIV drugs are toxic, the study's planners are hoping to learn whether delayed, discontinuous treatment for HIV is just as effective as the present strategy of immediate, uninterrupted treatment. The study will also gather information on the long-term side effects of HIV treatment and its effect on quality of life. Additionally, the study will seek to learn whether interruptions in treatment are associated with an increase in unsafe sex.

The study is open to anyone with HIV, male or female, who is at least 13 years old. To volunteer, you must have a T-cell count of at least 350 and you must be willing to start, stop, or change anti-HIV drug therapy, depending on the study group to which you are assigned. For the first year of the study, you will have to see the doctor once every two months. After that, you will see the doctor three times a year. For safety, you cannot volunteer for the study while you are pregnant, but you can volunteer after you have had your baby.

In Houston, this study will be available at three sites: Thomas Street Clinic, the Veteran's Administration Medical Center, and Montrose Clinic. The principal investigator (head doctor) for the study is Roberto Arduino, M.D., an associate professor of medicine at the University of Texas -- Houston Medical School.

For more information, call Hilda Cuervo at 1-713-500-6731.

Dr. Fehmida Visnegarwala (center) displays her award check for a new HIV/AIDS care compliance intervention study for women in underserved communities. Thomas Gegeny, Editor at The Center for AIDS, is on the left. Steven Nettles, of Bristol-Myers Squibb (the study sponsor), is on the right.

Compliance Study Launches at Thomas Street Clinic

Even though HIV disease has become a "chronic" disease, it is unlike many other chronic disease states (such as hypertension and diabetes) because compliance in HIV care has unparalleled social and public health influences. Many factors interfere with compliance, including continued substance abuse, competing subsistence needs (like housing, clothing, etc.), difficulties in accessing care and poor support from peer groups, employers and family members. All of these factors lead to failure to come for scheduled clinic appointments and to refill prescriptions on time. Thus, overall compliance is poor, which will likely limit options for future therapy, worsen disease outcome, and possibly even increase the potential for transmitting drug-resistant virus.

A new study is being launched at Houston's Thomas Street Clinic to look at interventions that might improve compliance among women in traditionally underserved populations. A grant for $243,000 was generously awarded by Bristol-Myers Squibb to fund the project. Dr. Fehmida Visnegarwala, Director of Education at Thomas Street Clinic and an assistant professor of medicine at Baylor College of Medicine, will oversee the study.

The study proposes to establish a quality improvement program for 100 women followed for an average of 18 months in an attempt to increase compliance with clinic visits and anti-HIV medications. This will be accomplished by providing patients with sufficient understanding of:

• the basic biology of HIV infection;

• the effects and limitations of presently available anti-HIV drugs; and

• the best ways to use health care resources to maximize response to therapy.

For those participants identified with active drug use, effective drug-rehabilitation services will be provided. The study will test if an intensive early-intervention program will give patients the desire and skills needed to use the health care delivery system to their best advantage. Women receiving care at Thomas Street Clinic are eligible to enroll in this study. For more information, contact Mary Caprio (1-713-873-4185).

Back to the HIV Treatment ALERTS! July 2001 contents page.