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Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
generic lopinavir/ritonavir
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Generic lopinavir/ritonavir, Pharmacokinetics, Pregnancy, Antiviral activity, Safety

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obsterics and Gynecology, Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

generic lopinavir/ritonavir

Outcomes

Primary Outcome Measures

To evaluate the pharmacokinetic profile of generic lopinavir/ritonavir tablets 200/50 mg in pregnant Thai HIV-infected women

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2008
Last Updated
July 15, 2020
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
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1. Study Identification

Unique Protocol Identification Number
NCT00621166
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Generic lopinavir/ritonavir, Pharmacokinetics, Pregnancy, Antiviral activity, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
generic lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
generic lopinavir/ritonavir
Intervention Description
Patients will start with lopinavir/ritonavir new formulation 400/100 mg bid with a low fat diet plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). The choice of the 2 NRTIs is at the discretion of the investigator, though in general the use of zidovudine+lamivudine (300/150mg Combivir®) is recommended. If patients can be included at or before gestational week 20, a 12h pharmacokinetic curve will be recorded at week 20 (± 2 weeks)(Group 1). There should be a minimum of 2 weeks between start of lopinavir and pharmacokinetic recording. If they are included after week 20, the first 12h pharmacokinetic curve will be recorded at gestational week 33 (± 2 weeks)(Group 2). For the patients in both groups a 12 hr curve will be recorded. Subjects in Group 1 will be offered to conduct a second 12h pharmacokinetic curve at week 20 (± 2 weeks), but this is only optional. Both groups will be asked to participate in the post partum curve, again this is optional.
Primary Outcome Measure Information:
Title
To evaluate the pharmacokinetic profile of generic lopinavir/ritonavir tablets 200/50 mg in pregnant Thai HIV-infected women
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surasith Chaithongwongwatthana, MD
Organizational Affiliation
Department of Obstetrics and Bynecology, Faculty of Medicine, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obsterics and Gynecology, Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.hivnat.org
Description
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women

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