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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Saquinavir, lopinavir, ritonavir

• Registration Number: NCT00400738
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Saquinavir, lopinavir, ritonavir	different dose per arm
2	Saquinavir, lopinavir, ritonavir	different dose per arm
3	Saquinavir, lopinavir, ritonavir	different dose per arm
4	Saquinavir, lopinavir, ritonavir	different dose per arm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The HIV Netherlands Australia Thailand Research Collaboration; 🇹🇭 Bangkok, Thailand