Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)

Phase 4

Recruiting

Conditions: HIV-infection
10047438
10010273

Registration Number: NL-OMON54597

Lead Sponsor: Apotheek Klinische Farmacie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

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 <4.6 mmol/L or <7.4 g/dL)
4. Using oral cabotegravir/rilpivirine.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics (AUC, Cmax, Cmin) of the agents under study in the second,<br /><br>third trimester of pregnancy related to the pharmacokinetics (AUC, Cmax, Cmin)<br /><br>at 4-6 weeks after delivery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Viral load of the pregnant female at screening, week 20, 33 of pregnancy and at<br /><br>4-6 weeks post-partum.<br /><br>Viral infection of the neonate.<br /><br>Transfer of antiretrovirals to breast milk (milk to blood ratio)</p><br>