Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125983
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-07-29
Brief Title:
Drug Interactions Between LopinavirRitonavir and Oral or Patch Contraceptives in HIV Infected Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Pharmacokinetic Study of the Transdermal Contraceptive System and Oral Contraceptive in HIV-1 Infected Women on LopinavirRitonavir
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the drug interactions between a protease inhibitor PI-based regimen including lopinavirritonavir LPVr and two forms of contraceptive medications in HIV infected women
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 LPVr and two forms of contraceptive medications Ortho Evra and an oral contraceptive Ortho Novum ON 135 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 mg100 mg LPVr 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 135 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
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 mg100 mg LPVr 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 135 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5188 | Registry Identifier | DAIDS ES | None |
| 10011 | REGISTRY | None | None |