periconceptional preventive therapy with anti-HIV drugs in women with a partner infected with HIV
- Conditions
- Prophylaxis against HIV infectionMedDRA version: 17.0Level: PTClassification code 10054925Term: Prophylaxis against HIV infectionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-003874-17-IT
- Lead Sponsor
- ational Institute for Infectious Diseases Lazzaro Spallanzani IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 30
• Age> 18 years (couple)
• HIV infected male partner on ARV treatment with plasma HIV RNA <40 copies / mL for at least 6 months
• Test HIVAb / Ag negative (female partner)
• No unprotected sex with HIV infected partner (female partner) or with other partners (couple) in the last 30 days
• Absence of sexually transmitted disease or infection (couple)
• Signing of Informed Consent (couple).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Female partner:
• Hepatitis B or nephropathy
• Presence of contraindications for Truvada as specified in the leaflet indications
• Use of psychoactive substances that may interfere with the patient's adherence to the prescribed medication regimen
• Participation in other Clinical Trial
couple:
• Subjects who, in the opinion of the investigator, does not ensure appropriate adherence to the study
• Inability to sign the informed consent.
• Signature of consent only by the female partner.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method