Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

HIV Infections Clinical Trial

Official title:

Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002224
• Other study ID #: 039G
• Secondary ID: AI454-158
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: April 13, 2011
• Start date: March 1999
• Est. completion date: March 1999

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Description:

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 1999
• Est. primary completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Are at least 18 years old.

• Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.

Exclusion Criteria

You will not be eligible for this study if you:

• Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)

• Have severe diarrhea.

• Are pregnant or breast-feeding.

• Have a history of pancreatic disease or any other serious condition.

• Have hepatitis within 30 days prior to study entry.

• Cannot take medications by mouth.

• Have received certain medications.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nelfinavir mesylate

• Stavudine

• Didanosine

Locations

Country	Name	City	State
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Clinique Medicale L'Actuele	Montreal	Quebec
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Sorra Research Ctr / Med Forum	Birmingham	Alabama
United States	Beacon Clinic / Boulder Community Hosp	Boulder	Colorado
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Nicholaos Bellos	Dallas	Texas
United States	Oak Lawn Physicians Group	Dallas	Texas
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Community Health Care	Fort Lauderdale	Florida
United States	HIV Clinical Research Ctr	Fort Lauderdale	Florida
United States	Immunity Care and Research Inc	Fort Lauderdale	Florida
United States	Houston Clinical Research Network / Div of Montrose Clinic	Houston	Texas
United States	Clinical Studies of Las Vegas	Las Vegas	Nevada
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	South Shore Hosp	Miami	Florida
United States	Coastal Carolina Research Ctr	Mount Pleasant	South Carolina
United States	Robert Scott MD	Oakland	California
United States	Univ of Nebraska Med Ctr	Omaha	Nebraska
United States	Anderson Clinical Research Inc	Reading	Pennsylvania
United States	Anderson Clinical Research Inc	Rego Park	New York
United States	Swedish Med Ctr	Seattle	Washington
United States	Saint Josephs Comprehensive Research Institute	Tampa	Florida
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm