HIV InfectionsPhase 4NCT00605098

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

A Phase 4 study testing Lopinavir / ritonavir and Lopinavir/ritonavir in people with HIV Infections and Pregnancy, run by Oswaldo Cruz Foundation at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: HIV Infections, Pregnancy
What is being tested?: Lopinavir / ritonavir and Lopinavir/ritonavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 3 sitesBrazil
Study dates: Feb 2008to Jul 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

Hospital Geral de Nova Iguaçu (HGNI)
Nova Iguaçu, Rio de Janeiro, 26030-380
Hospital dos Servidores do Estado
Rio de Janeiro, Rio de Janeiro, 20221903
Instituto de Pesquisa Clínica Evandro Chagas
Rio de Janeiro, Rio de Janeiro, 21040-900

Other trials in Brazil

About this study

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

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.

Conditions: HIV Infections, Pregnancy
Being tested: Lopinavir / ritonavir, Lopinavir/ritonavir
Keywords: HIV, Pregnancy, Vertical disease transmission, Pharmacokinetics, HIV seronegativity
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lopinavir / ritonavirDrug
Also called Kaletra
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/ritonavirDrug
Also called Kaletra
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.

Study groups in NCT00605098
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Lopinavir / ritonavir
2	Experimental	Not described Receives: Drug: Lopinavir/ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic parameters of the tablet formulation of lopinavir/r
Measured: Second and third pregnancy trimester and 6 weeks after delivery

Secondary outcomes (1)

Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood
Measured: Delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Jul 2012

First posted30 Jan 2008 (estimated)
Study startFeb 2008
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00605098
Sponsor's protocol ID: PK-LPV 01
Status last verified: Oct 2013
First submitted: 7 Jan 2008
Last updated: 28 Oct 2013
Results posted: No
Data monitoring committee: No

Publications

Santini-Oliveira M, Estrela Rde C, Veloso VG, Cattani VB, Yanavich C, Velasque L, Torres TS, Marins LM, Pilotto JH, Joao EC, Goncalves JC, Grinsztejn B. Randomized clinical trial comparing the pharmacokinetics of standard- and increased-dosage lopinavir-ritonavir coformulation tablets in HIV-positive pregnant women. Antimicrob Agents Chemother. 2014 May;58(5):2884-93. doi: 10.1128/AAC.02599-13. Epub 2014 Mar 10.
PubMed 24614377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy in HIV-infected Women
ClinicalTrials.gov ID: NCT00605098
Acronym / sponsor ID: PK-LPV 01
Conditions: HIV Infections, Pregnancy
Keywords: HIV, Pregnancy, Vertical disease transmission, Pharmacokinetics, HIV seronegativity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Oswaldo Cruz FoundationUniversity, hospital or other
Collaborators: Ministry of Health, Brazil
Study start: Feb 2008
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Lopinavir / ritonavir
2	Experimental	Drug: Lopinavir/ritonavir

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lopinavir / ritonavirAlso: KaletraLopinavir/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.	Drug	1
Lopinavir/ritonavirAlso: KaletraLopinavir/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.	Drug	2

Primary outcome

Pharmacokinetic parameters of the tablet formulation of lopinavir/r
Time frame: Second and third pregnancy trimester and 6 weeks after delivery

1 secondary outcome

Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood
Time frame: Delivery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
Derived from this study: PubMed 24614377Santini-Oliveira M, Estrela Rde C, Veloso VG, Cattani VB, Yanavich C, Velasque L, Torres TS, Marins LM, Pilotto JH, Joao EC, Goncalves JC, Grinsztejn B. Randomized clinical trial comparing the pharmacokinetics of standard- and increased-dosage lopinavir-ritonavir coformulation tablets in HIV-positive pregnant women. Antimicrob Agents Chemother. 2014 May;58(5):2884-93. doi: 10.1128/AAC.02599-13. Epub 2014 Mar 10.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marilia S Oliveira, MD principal investigator

IPEC - Oswaldo Cruz Foundation

Beatriz J Grinsztejn, MD principal investigator

IPEC - Oswaldo Cruz Foundation

Eduardo W Barroso, MD principal investigator

IPEC - Oswaldo Cruz Foundation

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lopinavir / ritonavir and Lopinavir/ritonavir in people with HIV Infections and Pregnancy, run by Oswaldo Cruz Foundation at 3 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters of the tablet formulation of lopinavir/r (time frame: Second and third pregnancy trimester and 6 weeks after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.