Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016601
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2001-05-18
Brief Title:
Depo-Medroxyprogesterone Acetate DMPA Depo-Provera Use With Certain Anti-HIV Drugs 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:
An Open-Label Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate DMPA Depo-Provera and Selected Protease Inhibitor PI and Nonnucleoside Reverse Transcriptase Inhibitor NNRTI Therapies Among HIV-Infected Women
Status:
COMPLETED
Status Verified Date:
2012-10
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 look at the level of depo-medroxyprogesterone acetate DMPA or Depo-Provera in the blood to see if is affected by certain anti-HIV drugs nelfinavir NFV efavirenz EFV indinavir IDV in combination with ritonavir RTV and nevirapine NVP This study will also look at the levels of these anti-HIV drugs to see if they are affected by DMPA
DMPA is a hormonal birth control method that is given as an injection It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA andor the amount of anti-HIV drugs in the blood If higher levels of DMPA occur side effects may increase If lower levels of anti-HIV drugs occur the drugs may become less effective against HIV This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together
DMPA is a hormonal birth control method that is given as an injection It is not known if taking DMPA together with anti-HIV drugs changes the amount of DMPA andor the amount of anti-HIV drugs in the blood If higher levels of DMPA occur side effects may increase If lower levels of anti-HIV drugs occur the drugs may become less effective against HIV This study will look at the levels of anti-HIV drugs and DMPA in the blood when these medications are used together
Detailed Description:
DMPA an injectable depot formulation of medroxyprogesterone MPA is a commonly used form of progestin-only contraception Information is limited on the specific P450 isozymes that metabolize MPA however it appears that CYP3A4 is 1 pathway of hepatic clearance Drugs known to be inhibitors of the CYP3A4 pathway such as protease inhibitors PIs may lead to elevated concentrations of MPA Secondly MPA given as DMPA injections has been shown to induce the activity of CYP3A4 by 25 percent It is possible that this action may result in enhanced clearance of the substrates of CYP3A4 including PIs and nonnucleoside reverse transcriptase inhibitors NNRTIs which in turn may result in reduced drug exposure and possible ARV failure This study is designed to address the lack of information on potential interactions between PIs or NNRTIs and DMPA
Patients are enrolled into 1 of 5 arms based on their current ARV regimen
Arm A control group No current ARVs or receiving nucleoside reverse transcriptase inhibitors NRTIs only
Arm B NFV 1250 mg bid or 750 mg tid in combination with NRTIs Arm C EFV 600 mg qd in combination with NRTIs Arm D IDV 800 mg bid and RTV 100 mg bid or 200 mg bid in combination with NRTIs
Arm E NVP 200 mg bid in combination with NRTIs Acceptable NRTIs and any fixed combination of these medications include zidovudine ZDV lamivudine didanosine stavudine d4T zalcitabine and abacavir concurrent therapy using ZDV and d4T is not allowed ARV therapy is not provided by this study One dose of DMPA is provided to all patients at entry Day 0 and an optional dose of DMPA will be available at the final visit Week 12 for those who are interested in continuing with DMPA outside of the protocol and who do not experience adverse events from the first DMPA injection Patients in Arms B C D and E have intensive pharmacokinetic sampling done at entry and at Week 4 to measure ARV levels All patients have blood tests at Weeks 2 4 6 8 10 and 12 to measure levels of DMPA and progesterone In addition tests to monitor HIV-1 RNA levels CD4 and CD8 counts hematology blood chemistries and liver function are performed periodically
Patients are enrolled into 1 of 5 arms based on their current ARV regimen
Arm A control group No current ARVs or receiving nucleoside reverse transcriptase inhibitors NRTIs only
Arm B NFV 1250 mg bid or 750 mg tid in combination with NRTIs Arm C EFV 600 mg qd in combination with NRTIs Arm D IDV 800 mg bid and RTV 100 mg bid or 200 mg bid in combination with NRTIs
Arm E NVP 200 mg bid in combination with NRTIs Acceptable NRTIs and any fixed combination of these medications include zidovudine ZDV lamivudine didanosine stavudine d4T zalcitabine and abacavir concurrent therapy using ZDV and d4T is not allowed ARV therapy is not provided by this study One dose of DMPA is provided to all patients at entry Day 0 and an optional dose of DMPA will be available at the final visit Week 12 for those who are interested in continuing with DMPA outside of the protocol and who do not experience adverse events from the first DMPA injection Patients in Arms B C D and E have intensive pharmacokinetic sampling done at entry and at Week 4 to measure ARV levels All patients have blood tests at Weeks 2 4 6 8 10 and 12 to measure levels of DMPA and progesterone In addition tests to monitor HIV-1 RNA levels CD4 and CD8 counts hematology blood chemistries and liver function are performed periodically
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5093 | None | None | None |