Study on concentrations of antiretroviral medicines in HIV0-infected pregnant women (PANNA)

Phase 1

• Conditions: HIV-infection in pregnant women; MedDRA version: 20.1Level: LLTClassification code 10020175Term: HIV infection with other conditionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2008-006158-16-GB
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-24
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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 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. Subject is pregnant
6. Subject is able to adhere to food intake recommendations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified