High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Lampiris, Harry W., M.D.
Updated on 7 November 2020
HIV Infection
protease
lopinavir
ritonavir
lopinavir/ritonavir
AIDS
drug test
kaletra
drug level

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of higher doses of lopinavir/ritonavir, in combination with other anti-HIV medications when administered as either the capsule or liquid formulations, among patients who have not had full viral suppression despite treatment with 3 classes of HIV medications, and at least 2 prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the active agents, lopinavir and ritonavir will be measured following administration of both the liquid and capsule formulations and compared.

Description

This study is a safety, efficacy, and tolerability study of high dose kaletra in patients who have failed multiple antiretroviral regimens, including prior treatment with 3 classes of antiretroviral drugs (nucleoside/nucleotide analogues, non-nucleoside analogues, and at least one protease inhibitor based ARV regimen), in conjunction with optimized background therapy. Patients will initially be treated with high dose kaletra capsules and optimized background therapy for 4 weeks and then switched to equivalent doses of high dose kaletra liquid formulation for a total duration of therapy of 24 weeks. The primary endpoint of the study will be the average HIV RNA change from baseline through 24 weeks (HIV RNA AACUMB). Secondary endpoints will include the proportion achieving HIV RNA < 50 and HIV RNA < 400 copies/mL at 24 weeks. Changes in CD4 from baseline, change in LPV fold change in phenotypic resistance testing, changes in fasting metabolic parameters, assessment of safety at week 24 based upon hematology, chemistry, liver function, lipid levels, proportion of patients reporting adverse events and proportion of patients with SAEs, and demonstration of bioequivalence by 12 hour pharmacokinetic measurements.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, AIDS
Treatment Kaletra (drug)
Clinical Study IdentifierNCT00247143
SponsorLampiris, Harry W., M.D.
Last Modified on7 November 2020

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note