Clinical trial NCT00621166: Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women
Official title: The Pharmacokinetics and Safety of Generic Lopinavir/Ritonavir (200/50 mg Tablets) 400/100 mg q12h in Thai HIV-infected Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Generic lopinavir/ritonavir
Pharmacokinetics
Pregnancy
Antiviral activity
Safety
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To investigate the possible influence of pregnancy and duration of pregnancy To determine the antiviral activity and safety of generic lopinavir/ritonavir® Compare pharmacokinetics parameters before and after pregnancy.

Detailed description: HAART in pregnant HIV-infected serves two goals, preventing mother to child transmission and providing adequate treatment for the mother. Levels of HIV RNA at delivery and the use of antiretrovirals (ARV) are independently associated with decreased transmission\[1\]. With a HAART regimen the transmission rate can be reduced till under the 2 %\[1, 2\]. Possibly suitable drugs which can be used during pregnancy is lopinavir/ritonavir based regimens. In Thailand, aluvir is not available therefore a generic lopinavir/ritonavir tablet formulation will be used in our study.

In order to prove adequate levels of lopinavir/ritonavir, we will record 12-hour PK at third trimester. Second trimester and post-partum 12-hour PK are optional. Furthermore, we will collect safety and efficacy throughout the study.

Eligibility criteria: Inclusion Criteria:

* Documented positive test for HIV-1 infection
* Subject is at least 18 and not older than 40 years of age at the day of the first dosing of study medication
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Pregnant for a maximum of 30 weeks at the day of first dosing of study medication

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the trial and the procedures required.
* Abnormal serum transaminases or creatinine, determined as levels being \> 3 times upper limit of normal.
* Concomitant use of medications that interfere with Generic lopinavir/ritonavir pharmacokinetics
* Active hepatobiliary or hepatic disease (N.B. chronic hepatitis B/C co-infection is allowed)
* Documented previous virological failure of a lopinavir/ritonavir containing regimen or documented resistance to lopinavir/ritonavir prior to dosing

Primary outcomes:
measure: To evaluate the pharmacokinetic profile of generic lopinavir/ritonavir tablets 200/50 mg in pregnant Thai HIV-infected women
timeFrame: 1 year
Secondary outcomes:
measure: To determine the antiviral activity of generic lopinavir/ritonavir 400/100 mg BID in Thai pregnant women To determine the safety of generic lopinavir/ritonavir® 400/100 mg BID in Thai pregnant women Compare pharmacokinetics parameters before and after
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Obsterics and Gynecology, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Department of Obstetrics and Bynecology, Faculty of Medicine, Chulalongkorn University
name: Surasith Chaithongwongwatthana, MD
role: PRINCIPAL_INVESTIGATOR
References: