Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy
This study is ongoing, but not recruiting participants.
Sponsor:
Oswaldo Cruz Foundation
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Marilia Santini de Oliveira, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00605098
First received: January 7, 2008
Last updated: March 22, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections Pregnancy |
Drug: Lopinavir / ritonavir Drug: Lopinavir/ritonavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Oswaldo Cruz Foundation:
Primary Outcome Measures:
- Pharmacokinetic parameters of the tablet formulation of lopinavir/r [ Time Frame: Second and third pregnancy trimester and 6 weeks after delivery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Ratio between the serum concentration of lopinavir/r in maternal blood and in cord blood [ Time Frame: Delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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) |
More Information
No publications provided
| 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 |
| Study First Received: | January 7, 2008 |
| Last Updated: | March 22, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Oswaldo Cruz Foundation:
|
HIV Pregnancy Vertical disease transmission Pharmacokinetics HIV seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 14, 2013
