The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Saquinavir, lopinavir, ritonavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00400738

HIV-NAT 019

Details and patient eligibility

About

Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.

Full description

Treatment with only protease inhibitors might benefit HIV patients, who experience problems with the other antiretrovirals drugs classes. Another reason to only use protease inhibitors is that the remaining classes are spared. This leaves the option to use these classes in the future, for instance in cases of drug resistance. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. written informed consent
2. ARV-naïve
3. HIV-1 infected Thai male or female > 18 years old
4. Documented positive test for HIV-1 infection

Exclusion criteria

1. Inability to understand the nature and extent of the study and the procedures required.
2. Pregnancy or lactating
3. Active opportunistic infection
4. ALT/ AST more than 2x upper limit
5. creatinine more than 1.5 time the upper limit
6. Smoke cigarettes more than 10 cigarettes a day.
7. Drink alcohol more than 2 units a day
8. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
9. Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

1

Experimental group

Description:

different dose per arm

Treatment:

Drug: Saquinavir, lopinavir, ritonavir

2

Experimental group

Description:

different dose per arm

Treatment:

Drug: Saquinavir, lopinavir, ritonavir

3

Experimental group

Description:

different dose per arm

Treatment:

Drug: Saquinavir, lopinavir, ritonavir

4

Experimental group

Description:

different dose per arm

Treatment:

Drug: Saquinavir, lopinavir, ritonavir