NCT01608269

Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Therapeutic Concepts · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.

Detailed description

Utilizing the ABC/3TC FDC tablets as the NRTI backbone, this open label study will compare the safety and efficacy of ABC/3TC when used as replacement for subjects with suboptimal CD4- cells count who are receiving TDF/FTC. TYhis study will be conducted for 48 weeks in HIV infected, HLA\*B5701 begative subjects who were initially suppressed on a HAART regiment that includes TDF/FTC QD.

Conditions

• HiV1- Positive

Interventions

Type	Name	Description
DRUG	Abacavir/Lamivudine	one tablet once a day

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-05-31
• Last updated: 2017-04-28

Locations

1 site across 1 country: United States