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
- 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 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.
- 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
| Drug name | Class | Dose and frequency |
# pt included | # patients needed (16-#included) |
|---|---|---|---|---|
| Efavirenz, Stocrin®, EFV | NNRTI | 600mg QD | 1 | 15 |
| Etravirine, Intelence®, TMC125 | NNRTI | 200mg BID | 1 | 15 |
| Emtricitabine, Emtriva® or FTC | NRTI | 200mg QD | 32 | 0 |
| Tenofovir, Viread®, TDF | NtRTI | 245mg QD | 36 | 0 |
| Atazanavir, Reyataz® | PI | 300/100mg RTV QD 400mgQD 400/100mg RTV QD |
22 | 1 |
| Fosamprenavir, Telzir®, FPV | PI | 700mg/100mg RTV BID 1400mg/200mg RTV QD |
2 | 14 |
| Darunavir, Prezista®, TMC114 | PI | 600mg/100mg RTV BID 800mg/100mg QD |
15 | 1 |
| 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 | 10 | 6 |
| Enfuvirtide, Fuzeon® | entry inhibitor | 90mg BID | 0 | 16 |
| Maraviroc, Celsentri® | entry inhibitor | 300mg BID | 2 | 14 |
