Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir
The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.
The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27516
- UNC Infectious Disease Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Women between 20-40 years of age with regular monthly menses
- If over age 35 then must not use tobacco
- Negative pregnancy test
- No known allergy to raltegravir
- No known history of phenylketonuria
- Undetectable HIV viral load
- No active liver disease as determined by medical history and normal AST and ALT
- No history of hepatic adenomas, carcinomas or benign liver tumors
- Ho history of thrombophlebitis of thromboembolic disease
- No history of deep vein thrombosis
- No history of cerebral vascular or coronary artery disease
- No known or suspected carcinoma of the breast
- No undiagnosed abnormal genital bleeding
- Not taking concomitant CYP 450 inducing medications such as anti-seizure medications
- No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening
- No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- Has used raltegravir prior to screening
- Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)
- Must not have had an abnormal pap test defined without resolution in the last 18 months.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Change in cervicovaginal fluide milieu
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gretchen S Stuart, MD, University of North Carolina, Chapel Hill
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 12-0832
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