Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
NCT ID: NCT00008489
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Didanosine
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Are at least 16 years old (consent of parent or guardian required if under 18).
* Are taking a stable Videx-containing anti-HIV regimen, using Videx tablets either once or twice a day, for at least 2 weeks prior to the screening visit.
* Score 2 or higher on the GSRS questionnaire for 1 or more of the following symptoms at the first 2 study visits: abdominal pain, nausea and vomiting, borborygmus, abdominal distension, and loose stools.
* Agree to use an effective barrier method of birth control during the study.
* Are available for at least 8 weeks.
Exclusion Criteria
* Are pregnant or breast-feeding.
* Are taking Videx in liquid form, nelfinavir, or amprenavir.
* Have a history of pancreatitis or gallstones.
* Abuse alcohol or require drugs which, in the opinion of the investigator, may increase the risk of pancreatitis.
* Have had treatment for an active opportunistic (AIDS-related) infection within 4 weeks of the screening visit. Patients with chronic candidiasis (yeast infection) or bacterial infection will be allowed.
* Are receiving or plan to receive chemotherapy for cancer.
* Plan to change their medications within 8 weeks following the screening visit.
* Are receiving investigational drugs or are participating in a clinical trial involving anti-HIV medications. Patients in Phase IV studies (studies that evaluate the long-term safety and effectiveness of a drug, usually after the drug has been approved by the FDA) may be eligible.
* Have an active, ongoing gastrointestinal disease or infection such as colitis, diverticulitis, Crohn's disease, peptic ulcer disease, giardiasis, or cryptosporidiosis.
* Are unable to take medications by mouth.
* Have severe diarrhea.
* Have peripheral neuropathy (a condition affecting the nervous system) or other condition or prior therapy that, in the opinion of the investigator, would affect the study.
16 Years
ALL
No
Sponsors
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PharmaResearch
INDUSTRY
Locations
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Altamed Medical Health Services
Los Angeles, California, United States
Tower ID Med Associates
Los Angeles, California, United States
Pacific Horizons Med Group
San Francisco, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Community Research Initiative of South Florida
Coral Gables, Florida, United States
Atlanta VA Med Ctr
Decatur, Georgia, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States
Park Nicollet Med Ctr / Hlth Education
Saint Louis Park, Minnesota, United States
Treatment for Life Ctr
Brooklyn, New York, United States
Jemsek Clinic
Huntersville, North Carolina, United States
Bornemann Internal Medicine
Reading, Pennsylvania, United States
Burnside Clinic
Columbia, South Carolina, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Countries
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Other Identifiers
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BMS-006
Identifier Type: -
Identifier Source: secondary_id
315A
Identifier Type: -
Identifier Source: org_study_id