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

HIV Infections Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400738
• Other study ID #: HIV-NAT 019
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2006
• Last updated: April 3, 2012
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2012
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Saquinavir, lopinavir, ritonavir
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

Locations

Country	Name	City	State
Thailand	The HIV Netherlands Australia Thailand Research Collaboration	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	International Antiviral Therapy Evaluation Center, Kirby Institute, Roche Pharma AG

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

van der Lugt J, Autar RS, Ubolyam S, Garcia EF, Sankote J, Avihingsanon A, Chuenyam T, Cooper DA, Lange J, Phanuphak P, Wit F, Ruxrungtham K, Burger D; HIV-NAT 019 Study Team. Pharmacokinetics and short-term efficacy of a double-boosted protease inhibitor regimen in treatment-naive HIV-1-infected adults. J Antimicrob Chemother. 2008 May;61(5):1145-53. doi: 10.1093/jac/dkn050. Epub 2008 Feb 18. Erratum in: J Antimicrob Chemother. 2008 Oct;62(4):852. Avihingson, Anchalee [corrected to Avihingsanon, Anchalee]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	study the pharmacokinetics of low dose and standard dose lopinavir/ritonavir and saquinavir HGC in ARV naive HIV-1 infected Thai patients		1 year	No
Secondary	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	No