EUCTR2014-003874-17-IT
Active, not recruiting
Phase 1
Antiretroviral Pre-exposure prophylaxis for natural conception (PrEP-C) in serodiscordant female partners of HIV-infected men in sustained virologic suppression
ational Institute for Infectious Diseases Lazzaro Spallanzani IRCCS0 sites30 target enrollmentSeptember 26, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Institute for Infectious Diseases Lazzaro Spallanzani IRCCS
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Not specified
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