Pharmacokinetics of Antiretroviral Agents in HIV-infected Pregnant Women. (PANNA)
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ClinicalTrials.gov Identifier: NCT00825929 |
Recruitment Status :
Recruiting
First Posted : January 21, 2009
Last Update Posted : December 1, 2022
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Condition or disease |
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HIV Infections |
The following agents will be studied:
Etravirine, Intelence, TMC125; Emtricitabine, Emtriva or FTC; Tenofovir, Viread, TDF; Atazanavir, Reyataz; Fosamprenavir, Telzir, FPV; Darunavir, Prezista, TMC114; Tipranavir, Aptivus, TPV; Indinavir, Crixivan; abacavir; raltegravir, Isentress; Enfuvirtide, Fuzeon; Maraviroc, Celsentri; dolutegravir; elvitegravir/cobicistat; rilpivirine, TAF, darunavir/cobicistat; doravirine; bictegravir
Study Type : | Observational |
Estimated Enrollment : | 176 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |
Official Title: | Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA) |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |

Group/Cohort |
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1
Treated with one of the antiretroviral agents under study, PK parameters during pregnancy will be compared with PK parameters after pregnancy (within the same woman)
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- Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery [ Time Frame: PK curve in Week 33 of pregnancy and 4-6 weeks after delivery ]
- Pharmacokinetics in the neonate, in case of post-exposure prophylaxis with one of the agents under study. [ Time Frame: Week 1, 3 and between 4 and 6 ]
- Safety of antiretrovirals during pregnancy [ Time Frame: GA Week 33 until end of trial ]
- viral load response and prevention of mother to child transmission of the virus [ Time Frame: GA Week 3 and at delivery ]
Biospecimen Retention: Samples Without DNA
Plasma samples will be collected in Week 33 of the pregnancy and at 4-6 weeks after delivery. At the following time points samples will be collected: T=0 (prior to dosing), and T=1, 2, 3, 4, 6, 8, 12 and 24h (24h sample only in case of QD regimen) post-dosing (8 or 9 samples).
In case the infant needs post-exposure prophylaxis with at least one of the agents sparse PK sampling is optional.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
- Subject is at least 18 years of age at screening.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Treated with an HAART regimen containing at least one agent which is mentioned in Appendix 1 of the protocol; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
- Duration of pregnancy not longer than 33 weeks at the day of screening
- Subject is able to adhere to food intake recommendations.
Exclusion Criteria:
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the study and the procedures required.
- Presence of grade III/IV anemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825929
Contact: David M Burger, PharmD PhD | ++31 24 3616405 | dadvid.burger@radboudumc.nl | |
Contact: Angela Colbers, MSc | ++31 24 3616405 | angela.colbers@radboudumc.nl |

Principal Investigator: | David M Burger, PharmD PhD | Radboud University Medical Centre Nijmegen |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Radboud University Medical Center |
ClinicalTrials.gov Identifier: | NCT00825929 |
Other Study ID Numbers: |
UMCN-AKF 08.02 |
First Posted: | January 21, 2009 Key Record Dates |
Last Update Posted: | December 1, 2022 |
Last Verified: | November 2022 |
pharmacokinetics pregnancy antiretrovirals |
neonates HIV treatment experienced |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |