Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00008489
Recruitment Status : Unknown
Verified January 2002 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : December 9, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Didanosine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Trial Comparing the Tolerability of Videx EC Capsules to Videx Tablets in Adults With HIV Infection

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Didanosine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008489

United States, California
Altamed Medical Health Services
Los Angeles, California, United States, 90022
Tower ID Med Associates
Los Angeles, California, United States, 90048
Pacific Horizons Med Group
San Francisco, California, United States, 94115
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
Burnside Clinic
Columbia, South Carolina, United States, 29206
Julio Arroyo
West Columbia, South Carolina, United States, 29169
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
Sponsors and Collaborators
PharmaResearch Identifier: NCT00008489     History of Changes
Other Study ID Numbers: 315A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: December 9, 2005
Last Verified: January 2002

Keywords provided by NIH AIDS Clinical Trials Information Service:
Gastrointestinal System
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents