Clinical trial
An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.
Name
ACH443-018
Description
To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.
Trial arms
Trial start
2006-09-01
Estimated PCD
2008-12-01
Trial end
2009-01-01
Status
Completed
Phase
Early phase I
Treatment
Elvucitabine
Elvucitabine 10 mg in combination with background ART
Lamivudine
Emtricitabine
Size
4
Primary endpoint
To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
September 2008
Eligibility criteria
Inclusion Criteria:
* Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.
Exclusion Criteria:
* Failure to meet inclusion criteria
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}
Updated at
2023-08-14
1 organization
3 products
1 indication
Organization
Alexion PharmaceuticalsProduct
LamivudineProduct
ElvucitabineProduct
Emtricitabine