Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to examine the drug interactions between a protease inhibitor (PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive medications in HIV infected women.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group
• Treatments: Contraceptive Agents; Contraceptives, Oral; Lopinavir; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Ortho Evra; Ritonavir

Criteria

Inclusion Criteria for All Participants:

• HIV infected

• CD4 count of 200 cells/mm3 or more within 45 days of study entry

• HIV-1 RNA viral load less than 55,000 copies/ml within 45 days of study entry

• Parent or guardian willing to provide informed consent

• Negative pregnancy test within 45 days of study entry

• Willing to use acceptable forms of contraception

• Agrees not to change current smoking or non-smoking habits

• Agrees not to consume caffeine on Day 1, Days 17 through 19, and Day 24 until after the last blood sample of that day is drawn

• Agrees not to consume alcohol within 48 hours of PK sampling periods

• Patients on methadone maintenance therapy should be on a stable methadone dose for at least 60 days prior to study entry and continue maintenance therapy throughout the study

Inclusion Criteria for Arm A Participants:

• Have taken LPV/r for at least 60 consecutive days prior to study entry and taken the same dose twice daily for at least 14 days prior to study entry. Women switching from capsule formulation LPV/r to new tablet formulation of 200mg/50 mg LPV/r must be taking twice-daily doses of this formulation, for a total daily dose of 800 mg/200 mg LPV/r, for at least 7 days prior to study entry.

Inclusion Criteria for Arm B Participants:

• Have not taken or currently not taking a PI- or non-nucleoside reverse transcriptase inhibitors (NNRTI-) based regimen for at least 30 days prior to study entry, and not planning on starting PIs or NNRTIs during the 6-week study period. Women who have not been on HAART for at least 30 days prior to study entry are also eligible.

• For patients not receiving HAART, documentation that they have been counseled about the benefits of HIV treatment within 90 days of study entry and have elected not to initiate therapy

Exclusion Criteria for All Participants:

• Use of systemic hormonal therapies containing estrogens, progestins, or anabolic steroids (e.g., estrogen, progesterone, oral contraceptives, Mirena [levonorgestrol] intrauterine device [IUD], Progestasert [progesterone] IUD) within 60 days of study entry

• Anabolic therapies (nandrolone decanoate or megestrol) within 60 days of study entry

• Systemic glucocorticoids within 14 days of study entry

• Certain medical conditions. More information on this criterion can be found in the protocol.

• Need for prolonged bedrest after major surgery

• Smokers of ages 35 or older

• NNRTIs within 30 days of study entry

• Nausea, vomiting, or abdominal pain of Grade 3 or higher within 30 days of study entry

• Known allergy or sensitivity to ethinyl estradiol (EE), norelgestromin (NGMN), or components of the Ortho Evra contraceptive patch

• Known allergy or sensitivity to norethindrone or components of the ON 1/35 oral contraceptive pill

• Serious illness requiring systemic treatment or hospitalization within 14 days of study entry

• Undiagnosed abnormal vaginal bleeding

• Depo-Provera (medroxyprogesterone acetate) within 180 days of study entry

• Lunelle (estradiol cypionate and medroxyprogesterone acetate) within 90 days of study entry

• Use of certain medications within 30 days of study entry

• Current drug or alcohol use or dependence that, in the opinion of the investigator, may interfere with the study

• Unable to adhere to HAART, the Ortho Evra contraceptive patch, or single dose ON 1/35 regimens