TRIALS NOW ENROLLING
Adefovir Dipivoxil for Antiretroviral Naive PatientsCRIA 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 PatientsCRIA 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.
Combination Study for Antiretroviral Naive PatientsCRIA is participating in a study comparing the three drug combination of Combivir (AZT/3TC) plus nelfinavir with the four drug combination of Combivir plus 1592U89 and the 141W94 protease inhibitor. To be eligible for the study participants must have a T-cell count of 50 or greater and a viral load of 5,000 or greater. The only prior treatment allowed is up to one week of 3TC or a protease inhibitor and up to four weeks with other nucleoside analog drugs. Participants will be reimbursed $15 per scheduled study visit after enrollment.
Twice a Day Crixivan StudyIn 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 undectectable viral load (less than 400 copies/ml), and have more than 100 T-cells. You must not have taken any other protease inhibitor. Participants will be reimbursed $15 per scheduled visit after enrollment.
DMP 266 (Sustiva) StudyDMP 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 LossOxandrolone 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 StudyCRIA 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 ProjectCRIA 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-RxCRIA 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 an updated listing of our trials, please call 212-924-3934.
This article was provided by AIDS Community Research Initiative of America. It is a part of the publication CRIA Update. Visit ACRIA's website to find out more about their activities, publications and services.