Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy

HIV Infections Clinical Trial

Official title:

Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy in HIV-infected Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605098
• Other study ID #: PK-LPV 01
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2008
• Last updated: October 25, 2013
• Start date: February 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2013
• Source: Oswaldo Cruz Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open, prospective and randomized study aimed at evaluating the pharmacokinetics of the tablet formulation of lopinavir/r administered in combination with two nucleoside analogs to HIV-infected pregnant women at two different dosages:

• Group 1 (standard dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours, plus two nucleoside analogs.

• Group 2 (increased dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours until the end of the second trimester of gestation (24 weeks) and 3 tablets every 12 hours in the third trimester (from 25 weeks on), plus two nucleoside analogs.

Treatment will be initiated at any time between 14 and 30 weeks of gestation and will be maintained for at least 6 weeks after delivery.

The objectives are:

• To compare the pharmacokinetic parameters of the standard and increased dosage of the tablet formulation of lopinavir/r during pregnancy.

• To determine whether the standard and/or increased dosage of the tablet formulation of lopinavir/r during pregnancy confers the same exposure to the drug as that observed in the same women after the end of pregnancy and in historic controls.

• To evaluate the transplacental passage of lopinavir/r based on the ratio between the serum concentration in maternal blood at the time of delivery and in cord blood of the two drug dosages (standard and increased) administered during pregnancy.

• To evaluate the tolerability of the two lopinavir/r dosages (standard and increased) during pregnancy.

• To describe the vertical transmission rate of HIV to the children of the pregnant women included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Capacity to consent and wish to participate in the study, documented by signing the specific informed consent form (ICF) of the study.

• Age of 18 years or older.

• Pregnancy documented by urine or blood examination or ultrasound.

• Gestational age of 14 to 30 weeks calculated by ultrasound, obstetric examination or date of last menstruation, depending on what is considered to be more exact by the medical investigator.

• HIV infection documented by two serological tests using different methods or analysis of HIV viral load with a positive result.

• No use of antiretroviral drugs at the time of diagnosis of pregnancy (previous prophylaxis and treatment are allowed).

• Intention to continue the treatment of the study for at least 6 weeks after delivery.

Exclusion Criteria:

• History of hypersensitivity to lopinavir or ritonavir.

• Need for the concomitant use of contraindicated drugs in combination with lopinavir/ritonavir.

• Any condition that, in the opinion of the medical researchers, impairs the participation in and fulfillment of the procedures of the study.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy

Intervention

Drug:
• Lopinavir / ritonavir
Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation and maintained for at least 6 weeks after delivery.
• Lopinavir/ritonavir
Lopinavir/r (200/50 mg, 2 tablets every 12 hours) plus two nucleoside analogs, starting at any time between 14 and 30 weeks of gestation, increase the lopinavir/r dosage (200/50 mg, 3 tablets every 12 hours) in the third trimester (from 25 weeks on), and return to standard dose(200/50 mg, 2 tablets every 12 hours)for at least 6 weeks after delivery.

Locations

Country	Name	City	State
Brazil	Hospital Geral de Nova Iguaçu (HGNI)	Nova Iguaçu	Rio de Janeiro
Brazil	Hospital dos Servidores do Estado	Rio de Janeiro
Brazil	Instituto de Pesquisa Clínica Evandro Chagas	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of the tablet formulation of lopinavir/r		Second and third pregnancy trimester and 6 weeks after delivery	No
Secondary	Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood		Delivery	No