A Trial of Lopinavir/Ritonavir Dosed According to the Who Pediatric Weight Band Dosing Guidelines

  • STATUS
    Recruiting
  • participants needed
    94
  • sponsor
    International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Updated on 8 November 2020
Investigator
Patricia Houston
Primary Contact
Howard University Washington, DC NICHD CRS (5044) (5.1 mi away) Contact
+55 other location
lopinavir
ritonavir
lopinavir/ritonavir
HIV Vaccine
kaletra

Summary

The main purpose of this study is to measure the amount of lopinavir/ritonavir (two anti-HIV medications) in the blood. Results from this study will be compared to the levels of the drugs that have been found in other studies that showed that these medications were safe and effective.

Description

This is a Phase II/III trial to assess the short-term pharmacokinetics, safety, and tolerance of LPV/r in HIV-infected infants and children initiating LPV/r therapy who weigh >3 and <25 kg and are dosed according to the WHO antiretroviral (ARV) weight band dosing guidelines. LPV/r will be administered as the heat-stable pediatric LPV/r 100/25 mg tablet in children who can swallow tablets or the liquid 80/20 mg/mL formulation in children who cannot swallow tablets. LPV/r will be dosed according to the WHO ARV weight band dosing schedule as part of a combination ARV regimen including two NRTIs as background therapy. The NRTI background will be prescribed by the health care provider according to local national and/or international guidelines for treatment of HIV-infected children. LPV/r will be provided as part of the study. The study duration, on treatment, will be 24 weeks.

Details
Treatment Lopinavir/ritonavir (LPV/r)
Clinical Study IdentifierNCT01338038
SponsorInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group
Last Modified on8 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

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

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

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

Learn more
Step 3 Enroll in the clinical study

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
Step 4 Get your study results

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

Study

user name

Annotated 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 made yet