Inclusion of patients

The target population of the PANNA study are HIV-infected pregnant women who have an indication for treatment with a HAART regimen containing a newly developed antiretroviral agent for which there is insufficient data available on the pharmacokinetics during pregnancy. The selection of the antiretroviral agents is at the discretion of the treating physician.

Inclusion criteria

  1. HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
  2. Subject is at least 18 years of age at screening.
  3. Subject is willing and able to sign the Informed Consent Form prior to screening evaluations.
  4. Treated with an HAART regimen containing at least one agent which is mentioned in Appendix 1; this agent has been taken for at least 2 weeks before the day of first PK curve evaluation.
  5. Subject is pregnant.
  6. Subject is able to adhere to food intake recommendations.

Exclusion criteria

  1. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  2. Inability to understand the nature and extent of the study and the procedures required.
  3. Presence of grade III/IV anaemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL).

Test products

Below you will find an overview of the antiretroviral agents that we will investigate in the PANNA study. The number of patients still needed is mentioned in the last column. Please contact the study centre near you to include a patient treated with one of these agents.

Inclusion of patients

Drug name Class Dose and
frequency
# pt included # patients needed
(16-#included)
Dolutegravir, Tivicay®, Triumeq®, DTG II 50mg QD 10 6
Elvitegravir, Vitekta®, Stribild®, EVG II 150mg QD/85mg QD 6 10
Cobicistat, in Stribild®, COBI booster 150mg QD 6 10
Darunavir/cobi, Rezolsta® PI 800mg/100mg DRV/COBI QD 0 16
Fosamprenavir, Telzir®, FPV PI 700mg/100mg RTV BID
1400mg/200mg RTV QD
3 13
Enfuvirtide, Fuzeon® entry inhibitor 90mg BID 2 14
Rilpivirine, Edurant®, TMC278 NNRTI 25mg QD 16 0, closed
Abacavir, Ziagen® NRTI 300mg BID 16 0, closed
Emtricitabine, Emtriva® or FTC NRTI 200mg QD 40 0, closed
Tenofovir, Viread®, TDF NtRTI 245mg QD 43 0, closed
Efavirenz, Stocrin®, EFV  

NNRTI

600mg QD 

16 

0, closed 
Etravirine, Intelence®, TMC125 

NNRTI 

200mg BID 

0, closed  
Atazanavir, Reyataz® PI 300/100mg RTV QD
400mgQD
400/100mg RTV QD
30 0, closed
Darunavir, Prezista®, TMC114 PI 600mg/100mg RTV BID
800mg/100mg QD
24 0, closed
Tipranavir, Aptivus®, TPV PI 500mg/200mg RTV BID 0 16
Indinavir, Crixivan® PI

800mg TID

800mg/100mg RTV BID

0 16
Raltegravir, Isentress® integrase inhib 400mg BID 21 0, closed
Maraviroc, Celsentri® entry inhibitor 300mg BID 7 0, closed