Overview

Pharmacokinetic and Efficacy of SQV/r 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg

Status:
Withdrawn

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500/100mg once daily plus TDF/FTC300/200mg once daily.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The HIV Netherlands Australia Thailand Research Collaboration

Treatments:

Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Ritonavir
Saquinavir
Tenofovir

Criteria

Inclusion Criteria:

1. written informed consent

2. All adults HIV patients previously included in the Gemini study and are currently
enrolled in HIV-NAT 006 and treated with SQV /r 1500/100 mg OD plus
tenofovir/emtricitabine (TDF/FTC) 300/200 mg once daily

Exclusion Criteria:

1. Inability to understand the nature and extent of the study and the procedures
required.

2. ALT/ AST more than 5x upper limit

3. Relevant history or current condition, illness that might interfere with drug
absorption, distribution, metabolism or excretion.

4. Use of concomitant medication that may interfere with the pharmacokinetics of
saquinavir, ritonavir, tenofovir or emtricitabine

5. History of sensitivity/idiosyncrasy to the drug or chemically related compounds which
may be employed in the study.

6. Active drug abuse