To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine
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ClinicalTrials.gov Identifier: NCT00207168 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: April 22, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
AIDS | Behavioral: Compliance | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |

- To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomized to receive either a once daily 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.
- To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential.
Exclusion Criteria:
- virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207168
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00207168 History of Changes |
Other Study ID Numbers: |
AI454-194 The TEddI Study |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | April 22, 2011 |
Last Verified: | April 2011 |