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Home > "C" Clinical Trials Conditions > Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)  Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)
Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).
Details: Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are at least 18 years old. - Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3. Exclusion Criteria You will not be eligible for this study if you: - Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.) - Have severe diarrhea. - Are pregnant or breast-feeding. - Have a history of pancreatic disease or any other serious condition. - Have hepatitis within 30 days prior to study entry. - Cannot take medications by mouth. - Have received certain medications.
Total Enrollment: 120
Location and Contact Information:
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359103
United States
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069
United States
Clinique Medicale du Quartier Latin
Montreal, Quebec,
Canada
Oak Lawn Physicians Group
Dallas, Texas, 75219
United States
Clinical Studies of Las Vegas
Las Vegas, Nevada, 89128
United States
South Shore Hosp
Miami, Florida, 33139
United States
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, 29464
United States
Clinique Medicale L'Actuele
Montreal, Quebec,
Canada
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
United States
Swedish Med Ctr
Seattle, Washington, 98122
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985400
United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
United States
Nicholaos Bellos
Dallas, Texas, 75246
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Community Health Care
Ft. Lauderdale, Florida, 33306
United States
Anderson Clinical Research Inc
Reading, Pennsylvania, 19604
United States
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
United States
HIV Clinical Research Ctr
Ft. Lauderdale, Florida, 33316
United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
United States
Robert Scott MD
Oakland, California, 94609
United States
Anderson Clinical Research Inc
Rego Park, New York, 11374
United States
Immunity Care and Research Inc
Ft. Lauderdale, Florida, 33311
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
Additional Information:
Study ID Numbers: 039G; AI454-158
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002224
Other Hiv Infections Studies:
1. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
2. A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
3. A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone
4. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
5. A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3
Related Studies:
Other HIV Infections Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)
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