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Sponsored by: |
PharmaResearch |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00008489 |
The purpose of this study is to compare gastrointestinal (stomach and intestines) side effects of 2 forms of Videx in HIV-infected patients.
Videx can be an effective anti-HIV treatment but many patients will not take the medication due to its side effects. Videx EC is a capsule form of the drug and may have fewer side effects. Also, patients would not have to take as many pills since patients taking Videx EC would have to take only 1 capsule per day instead of 2 tablets per day. This study will see if patients taking Videx EC have fewer side effects.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Didanosine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized Open-Label Trial Comparing the Tolerability of Videx EC Capsules to Videx Tablets in Adults With HIV Infection |
Estimated Enrollment: | 200 |
Despite its therapeutic advantages and proven efficacy in the treatment of HIV-infected patients, didanosine may continue to be underutilized because many patients experience undesirable gastrointestinal (GI) side effects and palatability problems. Once-daily dosing with Videx EC is expected to improve patient adherence with possible improved palatability and remove the GI side effects associated with the buffers included in the tablet. Videx EC once-daily dosing would improve pill burden by decreasing from 2 tablets to 1 capsule per day. Therefore, Videx EC may represent a significant step toward achieving better patient satisfaction, improved regimen adherence, and optimal virologic outcomes with Videx-containing regimens.
Patients are randomized to either continue their current Videx tablet-containing regimen for an additional 2 weeks or replace their Videx tablets with Videx EC. Patients who remain on Videx tablets are switched to the EC formulation at Study Week 2 for the remaining 4 weeks of the study period. For patients who continue and successfully complete the Week 6 study visit, an optional extended dosing period is offered until Videx EC becomes commercially available or the study funder terminates the study. Blood specimens for safety evaluations and viral load are collected at Weeks 0, 1, 2, 4, and 6. For patients participating in the extended dosing period, the visit schedule is every 8 weeks. Symptom scores between the 2 treatment groups are compared, with the primary comparison occurring at the Week 2 visit. Analyses include changes in GSRS scores administered by clinician interview at each study visit. Assessment of GI symptoms, palatability features, dosing convenience, lifestyle effects, and Videx preference is evaluated by the patient. Adverse events are assessed objectively by the observations of both the investigator and the patient.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Pacific Horizons Med Group | |
San Francisco, California, United States, 94115 | |
Tower ID Med Associates | |
Los Angeles, California, United States, 90048 | |
Altamed Medical Health Services | |
Los Angeles, California, United States, 90022 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Community Research Initiative of South Florida | |
Coral Gables, Florida, United States, 33146 | |
United States, Georgia | |
Atlanta VA Med Ctr | |
Decatur, Georgia, United States, 30033 | |
United States, Michigan | |
Wayne State Univ - WSU/DMC / Univ Hlth Ctr | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Park Nicollet Med Ctr / Hlth Education | |
St. Louis Park, Minnesota, United States, 55416 | |
United States, New York | |
Treatment for Life Ctr | |
Brooklyn, New York, United States, 112123198 | |
United States, North Carolina | |
Jemsek Clinic | |
Huntersville, North Carolina, United States, 28078 | |
United States, Pennsylvania | |
Bornemann Internal Medicine | |
Reading, Pennsylvania, United States, 19601 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
Burnside Clinic | |
Columbia, South Carolina, United States, 29206 | |
United States, Texas | |
Univ of Texas Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75235 | |
United States, Virginia | |
Hampton Roads Med Specialists | |
Hampton, Virginia, United States, 23666 |
Study ID Numbers: | 315A, BMS-006 |
Study First Received: | January 9, 2001 |
ClinicalTrials.gov Identifier: | NCT00008489 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Didanosine Gastrointestinal System Tablets |
Reverse Transcriptase Inhibitors Anti-HIV Agents Capsules |
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |