A5375
- Conditions
- -A169 Respiratory tuberculosis unspecified, without mention of bacteriological or histological confirmation-B24 Unspecified human immunodeficiency virus [HIV] diseaseRespiratory tuberculosis unspecified, without mention of bacteriological or histological confirmationUnspecified human immunodeficiency virus [HIV] diseaseA169B24
- Registration Number
- PER-024-19
- Lead Sponsor
- INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
1. Postmenarcheal female. 2. The following laboratory values obtained
within 30 days prior to study entry: • Absolute neutrophil count (ANC)
≥500 cells/mm3 • Platelet count ≥50,000 platelets/mm3 • Hemoglobin
≥8.0 g/dL • Aspartate transaminase (AST) <5 x upper limit of normal
(ULN) • Alanine aminotransferase (ALT) <5 x ULN • Creatinine ≤1.5 x ULN
• Total bilirubin ≤2.0 x ULN. 3. Negative serum or urine pregnancy test
within 30 days prior to study entry and within 48 hours prior to entry (if
screening occurs more than 48 hours prior to entry) The serum or urine
pregnancy test must have a sensitivity of at least 25 mIU/mL. 4. Has not
had sex that could lead to pregnancy without contraception within 14 days
prior to study entry. 5. Contraception requirements: All participants must
agree not to participate in a conception process (e.g., active attempt to
become pregnant or in vitro fertilization) for the duration of the study.
Women of reproductive potential, who are participating in sexual activity
that could lead to pregnancy, must agree to use at least one reliable
method of contraception while in the study. Acceptable forms of
contraceptives include: • Male condom with or without a spermicidal agent
• Diaphragm or cervical cap with spermicide • Non-hormonal IUD •
Bilateral tubal ligation • Male partner vasectomy. 6. Women and girls
major iqual to 16 years of age. 7. Ability and willingness of participant or
legal guardian/representative to provide informed consent. 8. BMI (kg/m2)
available at entry. Note: A maximum of 5 participants with BMI ≥30
kg/m2 will be allowed in each arm B-D and a maximum of 3 participants in
Arm A. 9. For women living with HIV: HIV-1 infection, documented by any
licensed rapid HIV test or HIV enzyme or chemiluminescence
immunoassay (E/CIA) test kit at any time prior to study entry and
confirmed by a licensed Western blot or a second antibody test by a
method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen,
plasma HIV-1 RNA viral load. 10. For women living with HIV: Receiving a
stable qualifying concomitant ART regimen containing either once-daily
DTG 50 mg or EFV 600 mg with no changes in the components of their
ART for at least 30 days prior to study entry. 11. For women who are
being treated for TB: HIV-negative at screening, documented within the
prior 6 months by any licensed rapid HIV test or HIV enzyme or
chemiluminescence immunoassay (E/CIA) test kit and confirmed by a
licensed Western blot or a second antibody test by a method other than
the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV-1
RNA viral load. 12. For women who are HIV-negative and being treated for
TB: Receiving RIF and INH on a once daily dosing (7 days per week)
schedule at study entry, after completion of the intensive phase of TB
treatment. Note: Inclusion of ethambutol as part of continuation phase of
TB therapy is allowed. 13 . Ability and willingness of participant to be
contacted remotely for study visits.
1. Known allergy/sensitivity or any hypersensitivity to LNG or components
of the formulation. 2. Bilateral oophorectomy, hysterectomy, or
postmenopausal. Note: Postmenopausal is defined as amenorrhea for at
least 12 consecutive months prior to study entry (in the absence of
medications known to induce amenorrhea), and have a documented
follicle stimulated hormone-release factor (FSH) measurement >40
mIU/mL or a result in the testing laboratory’s menopausal range. If an
FSH level is not available, 24 consecutive months of amenorrhea prior tostudy entry (in the absence of medications known to induce amenorrhea).
Note: Clinical assessment and clinician’s opinion are acceptable. 3.
Currently pregnant, within 6 weeks of delivery, or currently breastfeeding
an infant under 6 months of age. Note: For recent pregnancy resolution
during the first or second trimester, the participant is only eligible when
the pregnancy test result is negative. 4. Receipt of LNG within 30 days
prior to study entry. 5. Receipt of depo-medroxyprogesterone for 90 days
prior to study entry, or norethisterone enanthate (NET-EN) within 60 days
prior to study entry, or other hormonal contraceptives within 30 days prior
to study entry. 6. Use of any drugs other than RIF and EFV known to: 1)
induce CYP3A4 system within 30 days prior to study entry, and 2) inhibit
the CYP3A4 system within 7 days prior to study entry. See Appendix IV for
prohibited and precautionary medications. 7. Active drug or alcohol use or
dependence that, in the opinion of the site investigator, would interfere
with adherence to study requirements. 8. Acute or serious illness requiring
systemic treatment and/or hospitalization within 14 days prior to study
entry. 9. Other medical, psychiatric, or psychological condition that, in the
opinion of the site investigator, would interfere with completion of study
procedures and or adherence to study drug. 10. For women living with
HIV: Currently receiving medications for TB infection. 11. For women living
with HIV: Has missed one or more of the prescribed doses of HIV
medications within 3 days prior to study entry. Note: The entry visit may
be rescheduled within the screening period once the participant has taken
all prescribed doses within 3 days prior to study entry. 12. For women who
are HIV-negative and being treated for TB: Has missed one or more of the
prescribed doses of TB medication within 3 days prior to study entry.
Note: The entry visit may be rescheduled within the screening period once
the participant has taken all prescribed doses within 3 days prior to study
entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Area under the Curve<br>(AUC0-8h) for LNG.<br>Measure:Concentration of LNG<br>Timepoints:8 horas<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Occurrence of any SAE<br>potentially or definitely<br>related to LNG, or<br>occurrence of reportable<br>AEs potentially or<br>definitely associated<br>with LNG EC use during<br>study follow-up.<br>Measure:Safety<br>Timepoints:For 4 weeks<br>;<br>Outcome name:Maximum concentration<br>(Cmax), minimum<br>concentration (Cmin),<br>oral clearance (CL/F),<br>volume of distribution<br>(Vd), half-life (T1/2),<br>and area under the<br>Curve<br>Measure:PK estimates of LNG<br>Timepoints:For 24 hours (AUC0-24h),<br>48 hours (AUC0-48h), and<br>AUCinf (infinity) of LNG.<br>