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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00125983
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : November 1, 2021
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Pregnancy Drug: Lopinavir/ritonavir Drug: Ortho Novum 1/35 Drug: Ortho Evra Phase 2

Detailed Description:

Both PIs and oral contraceptives are metabolized by the same pathway, which significantly decreases the effectiveness of oral contraceptives and limits the contraceptive choices available to HIV infected women. More effective hormonal contraceptive methods are necessary for preventing unintended pregnancy in women taking highly active antiretroviral therapy (HAART). Ortho Evra is a contraceptive patch that was approved by the FDA in 2001; it uses a transdermal contraceptive system, and higher rates of compliance have been associated with its use, compared to oral contraceptives. Because Ortho Evra is administered as a contraceptive patch worn on the skin, it may bypass the metabolic pathway common to both PIs and oral contraceptives, making it a viable contraceptive option for HIV infected women on PI-based regimens. The purpose of the study is to examine the interaction between a PI-based regimen containing LPV/r and two forms of contraceptive medications, Ortho Evra and an oral contraceptive, Ortho Novum (ON 1/35), in HIV infected women.

Participants will be enrolled in this study for 6 weeks and will be assigned to one of two study arms, depending on their HAART regimen at study entry. Participants in both arms will also be stratified by age. Arm A participants will receive 400 mg/100 mg LPV/r twice daily along with two or more nucleoside reverse transcriptase inhibitors (NRTIs). Arm B participants will receive a regimen containing only NRTIs or no HAART. HAART will not be provided by this study. All patients will receive a single dose of ON 1/35 on Day 1 and will start the Ortho Evra contraceptive patch on Day 3. A physical exam, pap smear, pregnancy test, viral load test, CD4 and CD8 counts, and blood collection will occur at or before study entry and on Day 24. Pharmacokinetic analyses will occur on Days 1 through 3, 17 through 19, and 24.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Pharmacokinetic Study of the Transdermal Contraceptive System and Oral Contraceptive in HIV-1 Infected Women on Lopinavir/Ritonavir
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Days 17, 18, 19, and 24 Ortho Evra transdermal contraceptive ethinyl estradiol (EE) area under the concentration-time curve (AUC)

Secondary Outcome Measures :
  1. Intensive EE AUC pharmacokinetics (PK) after single dose Ortho Novum (ON) 1/35 and after Ortho Evra administration on Days 17, 18, 19, and 24
  2. Day 1 intensive EE AUC PK after single dose ON 1/35
  3. Days 17, 18, 19, and 24 norelgestromin (NGMN) AUC
  4. changes in HIV RNA viral load, CD4 and CD8 counts and their respective percentages, sex hormone binding globulin levels, and liver enzymes from baseline to Days 17, 18, 19, and 24
  5. occurrence of nausea and vomiting, breast tenderness, headache, skin irritation, vaginal bleeding, change in weight, change in blood pressure, change in appetite, mood changes, vaginal infection, and gallbladder disease
  6. PK parameters of LPV in Arm A at baseline and on Days 17, 18, 19, and 24

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125983

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United States, California
Los Angeles, California, United States, 90033-1079
Usc La Nichd Crs
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816-2396
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202-5250
United States, New York
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, United States, 10021
United States, Pennsylvania
Pitt CRS
Pittsburgh, Pennsylvania, United States
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
AIDS Clinical Trials Group
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Study Chair: Lori Kamemoto, MD, MPH Hawaii AIDS Clinical Research Program, University of Hawaii School of Medicine
Publications of Results:
Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00125983    
Other Study ID Numbers: A5188
10011 ( Registry Identifier: DAIDS ES )
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Birth Control Pills
Oral Contraceptives
Contraceptive Patch
Antiretroviral Therapy, Highly Active
Protease Inhibitor
Treatment Experienced
Treatment Naive
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ortho Evra
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female