Adefovir Dipivoxil for Antiretroviral Naive Patients
CRIA is participating in a 48 week study of Gilead Sciences' nucleotide analog drug adefovir dipivoxil (Preveon). Adefovir is a new type of drug that is active against HIV as well as some other viruses such as CMV, hepatitis B virus, and herpes viruses. The study is of HIV+ persons with more than 100 T-cells and HIV viral load of greater than 5,000 who have not taken other anti-HIV drugs in the past. Participants will be assigned to one of three treatments, all of which include the protease inhibitor indinavir (Crixivan). Participants will be reimbursed $15 per scheduled visit after enrollment.
Adefovir Dipivoxil for Protease Inhibitor Naive Patients
CRIA is also participating in a 48 week study of adefovir dipivoxil for HIV+ persons who have taken nucleoside analog drugs (e.g., AZT, 3TC, ddI, d4T, ddC) for at least four weeks. Participants will be switched to one of three possible combinations, all of which include adefovir dipivoxil and one or two protease inhibitors. To be eligible, participants must have more than 100 T-cells and a viral load greater than 5,000. Participants will be reimbursed $15 per scheduled visit after enrollment.
Fat Accumulation in the Belly (FAB) Study
Fat buildup in the abdomen may be a complication of protease inhibitor use. CRIA is studying the safety of daily human growth hormone injections as a possible treatment for this complication. To be eligible for this 24-week study, you must be HIV-infected, on stable antiretroviral therapy, and have noticed increasing abdominal size.
Twice a Day Crixivan StudyAdvertisementDMP 266 (Sustiva) Study
In this 24 week study, persons already taking Crixivan (indinavir) three times a day will be randomly assigned to continue this dose or change to 1200mg twice a day. To be eligible, you must be taking Crixivan plus two nucleoside drugs for the past 6 months, have undetectable viral load (less than 400 copies/ml), and have more than 100 T-cells. Participants will be reimbursed $15 per scheduled visit after enrollment.
DMP 266 is DuPont Merck's new non-nucleoside reverse transcriptase inhibitor
(NNRTI) that appears to be quite active against HIV in early clinical studies when used in combination with other drugs. CRIA is participating in a study of DMP 266 for people with more than 50 T-cells and HIV viral loads greater than 10,000 who have not taken a protease inhibitor drug, 3TC, nevirapine
, or delavirdine
. Participants will be assigned to one of three combinations: AZT + 3TC + indinavir (Crixivan), AZT + 3TC + DMP 266, or indinavir + DMP 266. The study will last 60 weeks and participants will be reimbursed $15 per scheduled study visit after enrollment.
Oxandrolone for Women with Weight Loss
Oxandrolone is BTG's anabolic steroid hormone which has shown promise as a treatment for AIDS-related wasting in small, preliminary studies and, unlike testosterone, can be taken as a pill. CRIA is participating in a multicenter study of oxandrolone for AIDS-related wasting in women. In this study, different doses of oxandrolone will be compared with inactive pills (placebo) for 12 weeks, followed by a 24 week period during which all participants will receive oxandrolone. Participants must be HIV+ with unintentional weight loss of 10-20% of their usual body weight. Participants will be reimbursed $15 per scheduled study visit after enrollment.
Protease Inhibitor and Blood Sugar Study
CRIA is conducting a study to examine the effects of protease inhibitor use on responses to the oral glucose tolerance test (measurement of blood sugar levels after taking a drink with a high sugar content). To be eligible, participants must be about to start treatment with a protease inhibitor drug for the first time. Participants will be reimbursed $30 for each of the first two visits and $50 for the final visit.
SMART/EST Women's Project
CRIA is participating in a multicenter study to test a 10 week stress management program to teach women how to cope more effectively with their illness and everyday problems. Two approaches -- individual and group relaxation training -- are being compared. Women 18 years of age and older with a diagnosis of AIDS may be eligible. Participants will be reimbursed $25 per visit after enrollment (up to $575). Free child care and refreshments will be provided. For more information, call Debra Munger at 212- 924-3934.
Testosterone and MET-Rx
CRIA is sponsoring a study of testosterone and MET-Rx, a high protein nutritional supplement for treatment of AIDS-related wasting. Participants will receive testosterone or placebo injections in combination with MET-Rx or standard nutritional supplement. Participants must be HIV+ men with T-cell counts of less that 400, low testosterone levels, and weight loss or loss of lean body mass. For information, call Dr. Judith Rabkin 212-543-5762.
FOR MORE INFORMATION ON ANY OF THESE STUDIES, PLEASE CALL DR. AVINASH DESAI OR DR. DOUGLAS MENDEZ AT (212) 924-3934.
For an updated listing of our trials, please call 212-924-3934.
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