Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002429

Collaborator

(none)

500

Enrollment

Locations

18.1

Duration (Months)

21.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine	Phase 3

Detailed Description

Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen

Study Start Date :

Jul 1, 1999

Actual Primary Completion Date :

Jan 1, 2001

Actual Study Completion Date :

Jan 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
Are at least 18 years old.
Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

Patients will not be eligible for this study if they:

Have had severe diarrhea within 30 days of study entry.
Have a history of pancreatic disease or any other serious condition.
Have hepatitis within 30 days of study entry.
Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
Are unable to take medications by mouth.
Have received certain medications.
Are pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sorra Research Ctr / Med Forum	Birmingham	Alabama	United States	35203
2	Body Positive	Phoenix	Arizona	United States	85016
3	AIDS Healthcare Foundation	Los Angeles	California	United States	900276069
4	San Francisco Gen Hosp	San Francisco	California	United States	94115
5	Med Alternatives	Fort Lauderdale	Florida	United States	33308
6	County Line Med CtrInc	Pembrook	Florida	United States	33023
7	Dr Gerald Pierone Jr	Vero Beach	Florida	United States	32960
8	The CORE Ctr	Chicago	Illinois	United States	60612
9	Indiana Univ Med Ctr	Indianapolis	Indiana	United States	462025250
10	Univ of Kansas School of Medicine	Wichita	Kansas	United States	672143124
11	Henry Ford Hosp	Detroit	Michigan	United States	48202
12	Dartmouth-Hitchcock Med Ctr	Lebanon	New Hampshire	United States	03756
13	NJCRI	Newark	New Jersey	United States	07103
14	Infectious Disease Assoc of Central Jersey	Somerville	New Jersey	United States	08876
15	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228
16	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15213
17	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
18	Gathe, Joseph, M.D.	Houston	Texas	United States	77004
19	Montrose Clinic	Houston	Texas	United States	77006
20	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666
21	Clinique Medicale du Quartier Latin	Montreal	Quebec	Canada
22	Clinique Medicale L'Actuele	Montreal	Quebec	Canada
23	Dr Roger P Leblanc	Montreal	Quebec	Canada