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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Didanosine
Sponsored by
PharmaResearch
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Gastrointestinal System, Tablets, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Capsules

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Altamed Medical Health Services
  • Tower ID Med Associates
  • Pacific Horizons Med Group
  • George Washington Univ Med Ctr
  • Community Research Initiative of South Florida
  • Atlanta VA Med Ctr
  • Wayne State Univ - WSU/DMC / Univ Hlth Ctr
  • Park Nicollet Med Ctr / Hlth Education
  • Treatment for Life Ctr
  • Jemsek Clinic
  • Bornemann Internal Medicine
  • Burnside Clinic
  • Julio Arroyo
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Hampton Roads Med Specialists

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 30, 2001
Last Updated
June 23, 2005
Sponsor
PharmaResearch
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1. Study Identification

Unique Protocol Identification Number
NCT00008489
Brief Title
Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
Official Title
A Randomized Open-Label Trial Comparing the Tolerability of Videx EC Capsules to Videx Tablets in Adults With HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
PharmaResearch

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Gastrointestinal System, Tablets, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Capsules

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Altamed Medical Health Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Atlanta VA Med Ctr
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Park Nicollet Med Ctr / Hlth Education
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Treatment for Life Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112123198
Country
United States
Facility Name
Jemsek Clinic
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Bornemann Internal Medicine
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19601
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

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

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