Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102986
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-02-04
Brief Title:
Differences in Blood Levels of LopinavirRitonavir in HIV Infected Men and Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Sex Differences in LopinavirRitonavir Pharmacokinetics Among HIV-1-Infected Men and Women
Status:
COMPLETED
Status Verified Date:
2015-12
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:
Mens and womens bodies may process anti-HIV drugs differently The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavirritonavir LPVr in HIV infected men and women
Detailed Description:
It is estimated that 50 of people living with HIVAIDS worldwide are women HIV infected women face different psychosocial issues than men and their bodies may react differently to HIV treatment However most of the data on the safety and efficacy of antiretrovirals ARVs used in the treatment of HIV infection are from studies conducted primarily in men LPVr in tablet form was approved by the FDA in October 2005 This study will determine the differences in pharmacokinetics PK in men and women taking a soft gel capsule and a tablet formulation of LPVr
No ARVs will be provided by this study In Step 1 participants will receive soft gel capsules of LPVr All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1 In Step 2 participants will receive tablets of LPVr During the study participants in both Step 1 and 2 will take a treatment regimen of LPVr twice daily and one or more of the following a nucleoside reverse transcriptase inhibitor NRTI tenofovir disoproxil fumarate or enfuvirtide Medical and medication history blood collection and clinical assessments will occur at study screening for both Steps 1 and 2 Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit The PK visit will occur within 30 days of study screening blood collection for PK analysis will also occur at this visit
No ARVs will be provided by this study In Step 1 participants will receive soft gel capsules of LPVr All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1 In Step 2 participants will receive tablets of LPVr During the study participants in both Step 1 and 2 will take a treatment regimen of LPVr twice daily and one or more of the following a nucleoside reverse transcriptase inhibitor NRTI tenofovir disoproxil fumarate or enfuvirtide Medical and medication history blood collection and clinical assessments will occur at study screening for both Steps 1 and 2 Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit The PK visit will occur within 30 days of study screening blood collection for PK analysis will also occur at this visit
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 |
|---|---|---|---|
| 10026 | REGISTRY | DAIDS ES | None |
| ACTG A5223 | None | None | None |