PK OF VAGINAL RING CONTRACEPTIVES AND ART

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-050-14
• Lead Sponsor: El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1. HIV-1 infection, documented.
2. Participants must be receiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART.
3. For participants on ART, documentation of plasma HIV-1 RNA 400 copies/mL
4. For participants not on ART, CD4+ cell count must be ≥350 cells/mm3
5. Laboratory values within 60 days prior to study entry: Platelet count ≥50,000 platelets/mm3, Hb ≥8.0 g/dL, SGOT and SGPT <5 x upper limit of normal (ULN), Cr ≤1.5 x ULN,Total bilirubin ≤2.0 x ULN
6. Last menstrual period 6 months prior to study entry.
7. Premenopausal females with at least one functioning ovary.
8. Documentation of Pap smear within 1 year prior to study entry.
9. Negative serum or urine-HCG pregnancy test with a sensitivity of ≤25 mIU/mL within 60 days prior to study entry
10. All participants must agree not to participate in a conception process
11. Women age ≥18 years old.
12. Women age 16-18 years old must be ≥40kg.
13. Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria

1. Received depot medroxyprogesterone acetate (DMPA) within 4 months prior to study entry.
2. Received other hormonal therapies within 30 days prior to study entry.
3. Breastfeeding.
4. Less than 6 weeks postpartum at study entry.
5. Use of any prohibited medications within 30 days prior to study entry
6. Initiated, discontinued, or changed doses of drugs that are CYP substrates or known to have drug interactions with ethinyl estradiol or etonogestrel
7. Bilateral oophorectomy.
8. For women older than 35 years of age, smoking 15 or more cigarettes per day.
9. History of invasive cancer of the reproductive tract.
10. Chronic immunosuppressive conditions other than HIV.
11. Use of systemic or inhaled corticosteroids such as for acute therapy for Pneumocystis pneumonia (PCP) or asthma exacerbation and prednisone ≥10 mg (or equivalent) for any reason other than a stable or tapering dose.
12. History of deep venous thrombosis or pulmonary embolism.
13. History of cerebral vascular or coronary artery disease.
14. Severe uncontrolled hypertension within 60 days prior to study entry.
15. Diabetes with vascular involvement.
16. Clinically active cervical or vaginal infection at study entry.
17. Acute infections or other opportunistic diseases requiring medication within 14 days prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified