Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy
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| ClinicalTrials.gov Identifier: NCT00605098 |
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Recruitment Status :
Completed
First Posted : January 30, 2008
Last Update Posted : October 28, 2013
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Sponsor:
Oswaldo Cruz Foundation
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Marilia Santini de Oliveira, Oswaldo Cruz Foundation
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Pregnancy | Drug: Lopinavir / ritonavir Drug: Lopinavir/ritonavir | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy in HIV-infected Women |
| Study Start Date : | February 2008 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | July 2012 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1 |
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.
Other Name: Kaletra |
| Experimental: 2 |
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, 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.
Other Name: Kaletra |
Primary Outcome Measures :
- Pharmacokinetic parameters of the tablet formulation of lopinavir/r [ Time Frame: Second and third pregnancy trimester and 6 weeks after delivery ]
Secondary Outcome Measures :
- Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood [ Time Frame: Delivery ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605098
Locations
| Brazil | |
| Hospital Geral de Nova Iguaçu (HGNI) | |
| Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380 | |
| Instituto de Pesquisa Clínica Evandro Chagas | |
| Rio de Janeiro, RJ, Brazil, 21040-900 | |
| Hospital dos Servidores do Estado | |
| Rio de Janeiro, Brazil, 20221903 | |
Sponsors and Collaborators
Oswaldo Cruz Foundation
Ministry of Health, Brazil
Investigators
| Principal Investigator: | Marilia S Oliveira, MD | IPEC - Oswaldo Cruz Foundation | |
| Principal Investigator: | Beatriz J Grinsztejn, MD | IPEC - Oswaldo Cruz Foundation | |
| Principal Investigator: | Eduardo W Barroso, MD | IPEC - Oswaldo Cruz Foundation | |
| Principal Investigator: | Valdilea G Veloso-Santos, MD | IPEC - Oswaldo Cruz Foundation | |
| Principal Investigator: | José Henrique S Pilotto, MD | Hospital Geral de Nova Iguaçu (HGNI) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marilia Santini de Oliveira, Medical doctor, Oswaldo Cruz Foundation |
| ClinicalTrials.gov Identifier: | NCT00605098 History of Changes |
| Other Study ID Numbers: |
PK-LPV 01 |
| First Posted: | January 30, 2008 Key Record Dates |
| Last Update Posted: | October 28, 2013 |
| Last Verified: | October 2013 |
Keywords provided by Marilia Santini de Oliveira, Oswaldo Cruz Foundation:
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HIV Pregnancy Vertical disease transmission Pharmacokinetics HIV seronegativity |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |