HIV-infection
Conditions
Interventions
None listed
Sponsors
Apotheek Klinische Farmacie
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: 1. HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot. 2. Subject is at least 18 years of age at screening. 3. Subject is able and willing 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. Duration of pregnancy not longer than 33 weeks at the day of screening 6. Subject is able to adhere to food intake recommendations.
Exclusion criteria
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 anemia (i.e. Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (AUC, Cmax, Cmin) of the agents under study in the second, third trimester of pregnancy related to the pharmacokinetics (AUC, Cmax, Cmin) at 4-6 weeks after delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral load of the pregnant female at screening, week 20, 33 of pregnancy and at 4-6 weeks post-partum. Viral infection of the neonate. Transfer of antiretrovirals to breast milk (milk to blood ratio) | — |
Countries
Netherlands
Outcome results
None listed