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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Oswaldo Cruz Foundation | Ministry of Health, Brazil |
Brazil,
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 |
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