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Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults Clinical research trials and Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults. Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults clinical trial. Subjects often receive the most expert healthcare possible for their Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults  Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): PharmaResearch ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 200
Location and Contact Information:
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Park Nicollet Med Ctr / Hlth Education
St. Louis Park, Minnesota, 55416
United States
Altamed Medical Health Services
Los Angeles, California, 90022
United States
Atlanta VA Med Ctr
Decatur, Georgia, 30033
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
Bornemann Internal Medicine
Reading, Pennsylvania, 19601
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
Treatment for Life Ctr
Brooklyn, New York, 112123198
United States
Tower ID Med Associates
Los Angeles, California, 90048
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Jemsek Clinic
Huntersville, North Carolina, 28078
United States
Additional Information:
Study ID Numbers: 315A; BMS-006
Study Start Date:
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008489
Other Hiv Infections Studies:
1. A Study to Evaluate the Ability of TNFR:Fc to Decrease the Amount of IL-6 (Interleukin-6) and TNF-alpha (Tumor Necrosis Factor) in HIV-Infected Patients
2. A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus
3. The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More than 12 Weeks
4. A Study of Patients with AIDS Syndrome
5. A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
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