Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089505
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2004-08-05
Brief Title:
NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
Optimal Combination Therapy After Nevirapine Exposure
Status:
COMPLETED
Status Verified Date:
2018-09
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:
OCTANE
Brief Summary:
Non-nucleoside reverse transcriptase inhibitors NNRTIs are commonly included in anti-HIV drug regimens However HIV infected women who have previously taken the single dose NNRTI nevirapine SD NVP for the prevention of mother-to-child transmission MTCT of HIV may not respond as well to NNRTIs as women who have never taken NVP Another class of anti-HIV drugs protease inhibitors PIs may be more effective for women who have previously taken NNRTIs This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have taken NVP for prevention of MTCT of HIV This study will also compare regimens including an NNRTI with regimens including a PI in women who have never taken NVP
Detailed Description:
NVP is the NNRTI of choice to prevent MTCT of HIV especially in resource-limited settings However prolonged use of NVP may result in drug resistance decreasing the efficacy of future anti-HIV regimens containing NVP PIs are more expensive and cause different adverse effects than NNRTIs but PI-containing regimens may be more effective than NNRTI-containing regimens in treating HIV infected women who previously took NVP for MTCT prophylaxis This study will compare the efficacy of NNRTI- and PI-containing anti-HIV regimens in women who have previously taken NVP for MTCT of HIV and in women who have never taken NVP
The study will last a minimum of 48 weeks Participants will be grouped by previous NVP exposure participants who have previously taken NVP as MTCT prophylaxis Trial 1 participants and participants who have never taken NVP Trial 2 participants Participants in each trial will be randomly assigned to one of two arms NVP-containing armNVPNVP for trial 1 participants and NoNVPNVP for trial 2 participants or PI-containing armNVPLPV_r for Trial 1 participants and NoNVPLPV_r for Trial 2 participants At the start of the study Arm NVPNVP and NoNVPNVP participants will receive emtricitabine FTC daily tenofovir disoproxil fumarate TDF daily and NVP daily for the first 14 days and then twice daily Arm NVPLPV_r and NoNVPLPV_r participants will receive both FTC and TDF daily and lopinavirritonavir LPVRTV twice daily FTC and TDF may be replaced in either arm with the combination drug FTCTDF
If participants experience virologic failure toxicity or otherwise cannot tolerate their regimens they will switch to a different regimen Arm NVPNVP and NoNVPNVP participants will switch to a regimen of two or more nucleoside reverse transcriptase inhibitors NRTIs and LPVRTV Arm NVPLPV_r and NoNVPLPV_r participants will switch to a regimen of two or more NRTIs and NVP Study visits will occur at entry and at Weeks 2 4 8 12 16 24 and then every 12 weeks thereafter Visits will consist of a physical exam medication assessment and blood collection Participants will be asked to complete adherence questionnaires at Weeks 4 12 24 and every 24 weeks thereafter and quality of life questionnaires at Weeks 24 and ever 24 weeks thereafter Study drugs will be provided for all participants through 48 weeks after the final participant is randomized
As per an amendment dated April 13 2009 participants will be asked to take part in an extension of this study Enrollment in the extension is completely voluntary The purpose of the extension is to monitor in greater extent the participants health as they transition from study treatment to local clinical care During the study extension participants will not receive any medications through the study it is expected that participants will receive their treatments through a local clinic
Participants enrolling in the extension will enter the extension at the same time as their last visit in the current study For the extension participants will be asked to come back to the clinic two times for study visits at 12 and 72 weeks after entry into the extension Because there will be a long time between these study visits participants will also be contacted by phone or through some other means close to 48 weeks after entry into the extension
At each of these visits participants will be asked about their health and medications including current anti-HIV drugs Participants will also be asked about any HIV care received outside of the study As part of this study investigators may need to review participants non-study medical records and speak with their non-study care providers to find out more about their HIV care and medical problems and also to check results of lab tests
During the study extension period participants will have blood drawn and also be tested for pregnancy
The study will last a minimum of 48 weeks Participants will be grouped by previous NVP exposure participants who have previously taken NVP as MTCT prophylaxis Trial 1 participants and participants who have never taken NVP Trial 2 participants Participants in each trial will be randomly assigned to one of two arms NVP-containing armNVPNVP for trial 1 participants and NoNVPNVP for trial 2 participants or PI-containing armNVPLPV_r for Trial 1 participants and NoNVPLPV_r for Trial 2 participants At the start of the study Arm NVPNVP and NoNVPNVP participants will receive emtricitabine FTC daily tenofovir disoproxil fumarate TDF daily and NVP daily for the first 14 days and then twice daily Arm NVPLPV_r and NoNVPLPV_r participants will receive both FTC and TDF daily and lopinavirritonavir LPVRTV twice daily FTC and TDF may be replaced in either arm with the combination drug FTCTDF
If participants experience virologic failure toxicity or otherwise cannot tolerate their regimens they will switch to a different regimen Arm NVPNVP and NoNVPNVP participants will switch to a regimen of two or more nucleoside reverse transcriptase inhibitors NRTIs and LPVRTV Arm NVPLPV_r and NoNVPLPV_r participants will switch to a regimen of two or more NRTIs and NVP Study visits will occur at entry and at Weeks 2 4 8 12 16 24 and then every 12 weeks thereafter Visits will consist of a physical exam medication assessment and blood collection Participants will be asked to complete adherence questionnaires at Weeks 4 12 24 and every 24 weeks thereafter and quality of life questionnaires at Weeks 24 and ever 24 weeks thereafter Study drugs will be provided for all participants through 48 weeks after the final participant is randomized
As per an amendment dated April 13 2009 participants will be asked to take part in an extension of this study Enrollment in the extension is completely voluntary The purpose of the extension is to monitor in greater extent the participants health as they transition from study treatment to local clinical care During the study extension participants will not receive any medications through the study it is expected that participants will receive their treatments through a local clinic
Participants enrolling in the extension will enter the extension at the same time as their last visit in the current study For the extension participants will be asked to come back to the clinic two times for study visits at 12 and 72 weeks after entry into the extension Because there will be a long time between these study visits participants will also be contacted by phone or through some other means close to 48 weeks after entry into the extension
At each of these visits participants will be asked about their health and medications including current anti-HIV drugs Participants will also be asked about any HIV care received outside of the study As part of this study investigators may need to review participants non-study medical records and speak with their non-study care providers to find out more about their HIV care and medical problems and also to check results of lab tests
During the study extension period participants will have blood drawn and also be tested for pregnancy
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 |
|---|---|---|---|
| 1U01AI068636 | NIH | None | None |
| OCTANE | US NIH GrantContract | None | httpsreporternihgovquickSearch1U01AI068636 |