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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Pharmacokinetics of and Rate of HIV-1 RNA Decline in ARV-naive HIV-1 Infected Patients Treated With Low- or Standard-dose Saquinavir HGC (Invirase®) and Lopinavir/Ritonavir (Kaletra®

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Saquinavir, lopinavir, ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent ARV-naïve HIV-1 infected Thai male or female > 18 years old Documented positive test for HIV-1 infection Exclusion Criteria: Inability to understand the nature and extent of the study and the procedures required. Pregnancy or lactating Active opportunistic infection ALT/ AST more than 2x upper limit creatinine more than 1.5 time the upper limit Smoke cigarettes more than 10 cigarettes a day. Drink alcohol more than 2 units a day Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>different dose per arm | Drug: Saquinavir, lopinavir, ritonavir<br>* arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID<br>|
| Experimental: 2<br>different dose per arm | Drug: Saquinavir, lopinavir, ritonavir<br>* arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID<br>|
| Experimental: 3<br>different dose per arm | Drug: Saquinavir, lopinavir, ritonavir<br>* arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID<br>|
| Experimental: 4<br>different dose per arm | Drug: Saquinavir, lopinavir, ritonavir<br>* arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study the pharmacokinetics of low dose and standard dose lopinavir/ritonavir and saquinavir HGC in ARV naive HIV-1 infected Thai patients |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe short-term tolerability, toxicity and efficacy of combinations of low-dose and standard dose lopinavir/ritonavir and saquinavirHGC given to the patients in this trial |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 infection, pharmacokinetics, protease inhibitor, double boosted protease inhibitors, PIs, Treatment Naive