Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Oswaldo Cruz Foundation Ministery of Health, Brazil |
---|---|
Information provided by: | Oswaldo Cruz Foundation |
ClinicalTrials.gov Identifier: | NCT00605098 |
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:
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:
Condition | Intervention | Phase |
---|---|---|
HIV Infections Pregnancy |
Drug: Lopinavir / ritonavir Drug: Lopinavir/ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy in HIV-Infected Women |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
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.
|
2: Experimental |
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marilia S Oliveira, MD | 55 21 3865-9662 | marilia.santini@ipec.fiocruz.br |
Contact: Beatriz J Grinzstejn, MD | 55 21 2270-7064 | gbeatriz@ipec.fiocruz.br |
Brazil, Rio de Janeiro | |
Hospital Geral de Nova Iguaçu (HGNI) | Recruiting |
Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380 | |
Principal Investigator: José Henrique S Pilotto, MD | |
Sub-Investigator: Jorge Eurico Ribeiro, MD | |
Brazil, RJ | |
Instituto de Pesquisa Clínica Evandro Chagas | Recruiting |
Rio de Janeiro, RJ, Brazil, 21040-900 | |
Contact: Valdiléa G Veloso-Santos, MD 55 21 3865-9550 valdilea.veloso@ipec.fiocruz.br | |
Principal Investigator: Marilia S Oliveira, MD | |
Principal Investigator: Beatriz J Grinsztejn, MD | |
Principal Investigator: Eduardo W Barroso, MD | |
Sub-Investigator: Luciana R Pitta, MSc | |
Sub-Investigator: Milton Ferreira Filho, PHd | |
Sub-Investigator: Marlice S Marques, PHd |
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) |
Responsible Party: | Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Oswaldo Cruz Foundation ( Marilia Santini de Oliveira ) |
Study ID Numbers: | PK-LPV 01 |
Study First Received: | January 7, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00605098 |
Health Authority: | Brazil: National Committee of Ethics in Research |
HIV Pregnancy Vertical disease transmission Pharmacokinetics HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |