TRIAL, NOT ERROR
Finding your way in the trials network
The AIDS Clinical Trials Group, or ACTG is the largest clinical trials network in the world. It is slated to spend $80 million dollars in the year 2000 alone. In the United States, two other groups sponsor trials: the Community Programs for Clinical Research on AIDS, or CPCRA, a community-based, activist-designed organization that reaches out to underserved groups, and the Veterans Administrations Network. Then there's the three-ring circus of drug- company-sponsored trials, many of which the AIDS Clinical Trials Information Service (ACTIS) doesn't list. Although it can be daunting to wade through these listings, it's worth the effort, especially if you're looking for answer to questions that matter to you. Another bonus: Most trials provide participants with quality HIV care and access to drugs and tests that would otherwise be too expensive.
Many local publications list currently-enrolling drug trials; ACTIS (800-TRIALS-A or www.actis.org) lists many studies around the country. So does the regularly updated HIV/AIDS Treatment Directory, published by the American Foundation for AIDS Research (amfAR), (available online at www.amfar.org/td) and The Experimental Treatment Guide for the Northeast Region, published by the AIDS Treatment Data Network (ATDN); online at www.aidsinfonyc.org/network) or by calling 800-734-7104.
We've reached into the grabbag of ongoing and upcoming ACTG-sponsored trials and come up with an interesting sample. Still feel like you don't fit in? Have a burning question? Ask your doctor to put you in touch with other women who've been through clinical trials, and discuss current research that might benefit you. Remember, you are an expert too.
Observing OIs
ACTG 5029 is an observational study of human papillomavirus, or HPV, the virus that causes genital warts and cervical cancer, in women starting antiretroviral drugs for the first time. What you might learn: Whether HIV combination therapy can help control HPV as well as HIV. What it may involve: pelvic exams and taking a combination regimen. Who can enroll: PI- and NNRTI-naive women who enroll in ACTG or industry-sponsored trials, Phase II and up.
Pregnancy and PIs
PACTG 5084 looks at the safety of different antiretroviral regimens in pregnant women, with a focus on glucose, or blood sugar, levels. What you might learn: Protease drugs cause changes in blood chemistry, and pregnancy brings major hormonal upheaval. What happens when the body's dealing with both at the same time? What it may involve: blood draws and oral glucose tolerance tests. Who can enroll: pregnant women, 20 to 30 weeks gestation.
Life goes on
ACTG 5015 will track viral load, CD4 T-cell counts, and other markers in two age-differentiated groups of men and women to get an idea of how age affects disease progression. What you might learn: the difference between HIV in young and older (over 45) women.. How do menopause and HIV therapy affect viral load, particularly in genital secretions? What it may involve: viral load and CD4 tests, hormone-level tests, and other tests of immune function. Who can enroll: women aged 13 to 30 and over 45 with less than two weeks of previous antiretroviral therapy and up to 600 CD4 T-cells, with a viral load greater than 2000 copies.
AWARE AND ALIVE
ALLRT (ACTG Longitudinal Linked Randomized Trials) or A5001 is a prime example of the next generation of large-scale, long-term trials. With a targeted enrollment of 2,750 men and women, ALLRT will track the twists and turns of life on therapy. What you might learn: how hormone replacement therapy or just being a woman affects viral control and the strength of the immune system. What it may involve: three visits a year, to a site, blood draw, and questionnaires. Who can enroll: To be in ALLRT, you have to be enrolled in one of several ACTG studies, each with different criteria. Some were still open at press time.
- EB
