periconceptional preventive therapy with anti-HIV drugs in women with a partner infected with HIV

Antiretroviral Pre-exposure prophylaxis for natural conception (PrEP-C) in serodiscordant female partners of HIV-infected men in sustained virologic suppression

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003874-17-IT

Enrollment

Registered

2014-09-26

Start date

2014-12-22

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis against HIV infection MedDRA version: 17.0 Level: PT Classification code 10054925 Term: Prophylaxis against HIV infection System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: TRUVADA*30CPR RIV 200MG/245MG Product Name: Truvada (Emtricitabina/Tenofovir Disoproxil) Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age> 18 years (couple) • HIV infected male partner on ARV treatment with plasma HIV RNA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Allowing serodiscordant couples wishing to conceive, in which the male partner is HIV positive with undetectable viral load and the female partner is HIV negative, to conceive naturally in the absence of HIV transmission using the method of pre-exposure prophylaxis (PrEP-C).;Secondary Objective: Assess the acceptability of the assumption of Truvada and PrEPC method in serodiscordant couples wishing to conceive Assess drug adherence in HIV-negative female partners To evaluate the tolerability of Truvada used for PrEP-C ;Primary end point(s): • Number of couples enrolled in PrEP / Number of couples observed. • Number of pregnancies per number of PrEP-C cycles performed and per couple • Rate of HIV seroconversion per number of PrEP cycles and number of reported sexual intercourses. • Acceptability of treatment.;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: Allowing serodiscordant couples wishing to conceive, in which the male partner is HIV positive with undetectable viral load and the female partner is HIV negative, to conceive naturally in the absence of HIV transmission using the method of pre-exposure prophylaxis (PrEP-C).;Secondary Objective: Assess the acceptability of the assumption of Truvada and PrEPC method in serodiscordant couples wishing to conceive Assess drug adherence in HIV-negative female partners To evaluate the tolerability of Truvada used for PrEP-C ;Primary end point(s): • Number of couples enrolled in PrEP / Number of couples observed. • Number of pregnancies per number of PrEP-C cycles performed and per couple • Rate of HIV seroconversion per number of PrEP cycles and number of reported sexual intercourses. • Acceptability of treatment.;Timepoint(s) of evaluation of this end point: 36 months

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 36 months;Secondary end point(s): • Adherence: doses taken / planned doses of PrEP-C. • Tolerability of treatment	—

Countries

Italy

Contacts

Public ContactCentro di riferimento AIDS

National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS

irapep@inmi.it+390655170930

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026