Study of the effect of pregnancy on the concentrations of antiretroviral drugs in the blood of women with HIV infectio

• Conditions: HIV-1 infection; MedDRA version: 14.1Level: LLTClassification code 10008922Term: Chronic infection with HIVSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005270-35-IT
• Lead Sponsor: ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-02
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Pregnant women (> 18 years) receiving HAART or who start HAART (standard dose);
-Signature of appropriate informed consent;
-Administration of antiretroviral drugs as indicated in the data sheet for each product.
- Subject-able to adhere to the recommended diet.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any disease-AIDS-defining active at enrollment.
Presence of a new diagnosis of opportunistic infection or HIV-relata of any medical condition that requires immediate treatment at enrollment.
-Presence of anemia grade III / IV (Hb <4.6 mmol / L or <7.4 g / dL)
Presence of relevant conditions, current or past, which could interfere with the absorption, distribution, metabolism and elimination of drugs.
Any active-obstetric complication requiring interruption of HAART, or the administration of therapies not covered in the study.
Any abnormal fetal-known.
Clinically relevant disease-active, which in the opinion of the investigator, could compromise the safety of the patient or the result of the study.
-Any condition that, in the opinion of the investigator, may compromise the safety of the patient and the membership or protocol.
-Any contraindication to the use of antiretroviral drugs, as therapeutic indications.
-Creatinine clearance <50 mL / min at screening or evidence of renal involute years;
-Use of psychoactive substances that may in any way interfere with the patient's adherence to the prescribed regimen;
-Persons who, in the opinion of the investigator, does not ensure adequate adherence to the study;
-Patients who are receiving or have received antineoplastic or immunomodulatory activities over the past 12 months;
- Participation in other clinical trials with experimental drugs or medication during the 30 days prior to entry in the protocol;
- Inability to sign informed consent.

Study & Design

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