Inclusion of patients

The target population of the PANNA study are HIV-infected pregnant women who have an indication for treatment with a cART 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

  • HIV-infected as documented by positive HIV antibody test and confirmed by an antigen test.
  • Subject is at least 18 years of age at screening.
  • Subject is willing and able to sign the Informed Consent Form prior to screening evaluations.
  • Treated with a cART 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.
  • Subject is pregnant.
  • 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 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

Class
Dose and frequency
# pt included
# patients needed (16-#included)
Bictegravir, Biktarvy®, BIC
II
50mg QD
14
2
Doravirine, Pifeltro®, Delstrigo®, DORA
NNRTI
100mg QD
1
15
Raltegravir, Issentress®, RAL
II
1200mg QD
4
12
Fosamprenavir, Telzir®, FPV
PI
700mg/100mg RTV BID 1400mg/200mg RTV QD
3
13
Enfuvirtide, Fuzeon®
entry inhibitor
90mg BID
2
14
Dolutegravir, Tivicay®, Triumeq®, DTG
II
50mg QD
23
0, closed
Tenofovir alafenamide, Descovy®, Genvoya®, Odefsey®, TAF
NRTI
10mg / 25mg QD
23
0, closed
Elvitegravir, Vitekta®, Stribild®, EVG
II
150mg QD/85mg QD
14
0, closed
Cobicistat, in Stribild®, COBI
booster
150mg QD
14
0, closed
Darunavir/cobi, Rezolsta®
PI
800mg/100mg DRV/COBI QD
2
0, closed
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
5
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
Cabotegravir (Vocabria®), rilpivirine (Rekambys®)
II/NNRTI/LA
1 injection/8 weeks
1
15