|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002429 |
Purpose
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 | Intervention | Phase |
|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine |
Phase III |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Zidovudine Lamivudine Didanosine Stavudine Nelfinavir Nelfinavir Mesylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | July 1999 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations![]() |
Show 23 Study Locations |
| Bristol-Myers Squibb |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
  |
|
Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)
  |
| Study ID Numbers: | 039F, AI454-152 |
| First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002429 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|
|