HIV-1 infection MedDRA version: 14.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: VIRAMUNE*60CPR 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: NEVIRAPINE
CAS Number: 129618-40-2
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligra
Sponsors
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the trend of the antiretroviral drugs' concentrations (C trough and PK curve,when available) during the three trimesters of pregnancy, at delivery and at postpartum and to compare the pharmacokinetic data with the results in terms of virological suppression (<50 cp HIV-RNA/ml) at delivery and during the period immediately following (the sixth and twelfth month after birth).;Secondary Objective: # To evaluate the spread in the body side compartments (amniotic fluid, cord blood) of antiretroviral drugs most commonly used in pregnancy. # To compare the drug's concentration measured in umbilical cord blood (CB) and amniotic fluid (AF) with those measured in maternal blood, by calculating the respective ratios (the ratio CB: M ratio AF: M). # To compare the pharmacokinetic results, including the C: M, with the results of clinical nenato. # To evaluate the safety and tolerability of antiretroviral drugs during pregnancy.;Primary end point(s): To compare the pharmacokinetic of antiretroviral drugs during the third trimester of pregnancy with the results in terms of virological suppression (<50 cp HIV-RNA/ml) at delivery and during the period immediately following.;Timepoint(s) of evaluation of this end point: The study will have a total duration of 144 weeks of which: Enrollment: 48 weeks; Study: 48 weeks; Follow up: 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the propagation of the most commonly used antiretroviral drugs of in secondary compartments: amniotic fluid and cord blood.;Timepoint(s) of evaluation of this end point: The study will have a total duration of 144 weeks of which: Enrollment: 48 weeks; Study: 48 weeks; Follow up: 48 weeks. | — |
Countries
Italy
Contacts
Public ContactDay Service Unificato
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Outcome results
None listed