Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Didanosine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: PharmaResearch
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.
Clinical Details
Official title: A Randomized Open-Label Trial Comparing the Tolerability of Videx EC Capsules to Videx Tablets in Adults With HIV Infection
Study design: Primary Purpose: Treatment
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- 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
Patients will not be eligible for this study if they:
- 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.
Locations and Contacts
Altamed Medical Health Services, Los Angeles, California 90022, United States
Tower ID Med Associates, Los Angeles, California 90048, United States
Pacific Horizons Med Group, San Francisco, California 94115, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Community Research Initiative of South Florida, Coral Gables, Florida 33146, United States
Atlanta VA Med Ctr, Decatur, Georgia 30033, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit, Michigan 48201, United States
Park Nicollet Med Ctr / Hlth Education, St. Louis Park, Minnesota 55416, United States
Treatment for Life Ctr, Brooklyn, New York 112123198, United States
Jemsek Clinic, Huntersville, North Carolina 28078, United States
Bornemann Internal Medicine, Reading, Pennsylvania 19601, United States
Burnside Clinic, Columbia, South Carolina 29206, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Additional Information
Last updated: December 8, 2005
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