Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
- Conditions
- HIV Infections
- Registration Number
- NCT00008489
- Lead Sponsor
- PharmaResearch
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Park Nicollet Med Ctr / Hlth Education
🇺🇸St. Louis Park, Minnesota, United States
Jemsek Clinic
🇺🇸Huntersville, North Carolina, United States
Community Research Initiative of South Florida
🇺🇸Coral Gables, Florida, United States
Bornemann Internal Medicine
🇺🇸Reading, Pennsylvania, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
🇺🇸Detroit, Michigan, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Altamed Medical Health Services
🇺🇸Los Angeles, California, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
Atlanta VA Med Ctr
🇺🇸Decatur, Georgia, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Burnside Clinic
🇺🇸Columbia, South Carolina, United States
Treatment for Life Ctr
🇺🇸Brooklyn, New York, United States