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

NCT00008489 | Unknown Phase 3

• 2 other identifiers: 315ABMS-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

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.

Conditions

HIV Infections

Keywords

Didanosine; Gastrointestinal System; Tablets; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Capsules

Interventions

Didanosine DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaResearch: lead

Study Sites (15)

Altamed Medical Health Services

Los Angeles, California, 90022, United States

Location

Tower ID Med Associates

Los Angeles, California, 90048, United States

Location

Pacific Horizons Med Group

San Francisco, California, 94115, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Community Research Initiative of South Florida

Coral Gables, Florida, 33146, United States

Location

Atlanta VA Med Ctr

Decatur, Georgia, 30033, United States

Location

Wayne State Univ - WSU/DMC / Univ Hlth Ctr

Detroit, Michigan, 48201, United States

Location

Park Nicollet Med Ctr / Hlth Education

Saint Louis Park, Minnesota, 55416, United States

Location

Treatment for Life Ctr

Brooklyn, New York, 112123198, United States

Location

Jemsek Clinic

Huntersville, North Carolina, 28078, United States

Location

Bornemann Internal Medicine

Reading, Pennsylvania, 19601, United States

Location

Burnside Clinic

Columbia, South Carolina, 29206, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Hampton Roads Med Specialists

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2001
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2002-01

Locations

US (15)