Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044837
Status:
TERMINATED
Last Update Posted:
2015-06-04
First Post:
2002-09-05
Brief Title:
Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected Postmenopausal 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 I Pharmacokinetic Study of Hormone Replacement Therapy in HIV-1-Infected Postmenopausal Women on Nelfinavir LopinavirRitonavir or Efavirenz
Status:
TERMINATED
Status Verified Date:
2003-06
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 find out if the anti-HIV drugs nelfinavir NFV lopinavirritonavir LPVr and efavirenz EFV change the amount of estrogen in the blood when taken along with hormone replacement therapy HRT for menopause
HRT can be helpful for treating bothersome symptoms of menopause However it is not routinely used in HIV-infected postmenopausal women because it is not known how HRT interacts with anti-HIV drugs The information obtained from this study will help doctors make recommendations for HRT in postmenopausal HIV-infected women
HRT can be helpful for treating bothersome symptoms of menopause However it is not routinely used in HIV-infected postmenopausal women because it is not known how HRT interacts with anti-HIV drugs The information obtained from this study will help doctors make recommendations for HRT in postmenopausal HIV-infected women
Detailed Description:
The benefits of hormone replacement therapy HRT in HIV-negative postmenopausal women include the abatement of menopausal symptoms such as hot flashes insomnia mood changes vaginal dryness urogenital and skin changes and memory loss HRT may also decrease risk for primary cardiovascular disease osteoporosis colon cancer and possibly Alzheimers disease and age-related macular degeneration There may also be an overall survival benefit for HIV-negative postmenopausal women taking hormone replacement therapy Despite the potential benefits of postmenopausal hormone replacement it is seldom used in HIV-infected postmenopausal women One concern about HRT in HIV-infected women is the potential for interaction with antiretroviral ARV drugs Although the effect of HRT on ARV drug levels is likely to be small it is important to evaluate the safety of administering HRT concurrently with ARVs The information obtained from this study will help shape recommendations for postmenopausal HRT in HIV-infected women
Patients are enrolled into 1 of 4 study arms based on their current oral ARV regimens Arm A takes NFV plus nucleoside reverse transcriptase inhibitors NRTIs Arm B takes LPVr plus NRTIs Arm C takes EFV plus NRTIs Arm D enrolls HIV-infected patients not on current ARVs or who are taking NRTIs only no protease inhibitors PIs or nonnucleoside reverse transcriptase inhibitors NNRTIs All arms receive HRT with oral estradiol and medroxyprogesterone acetate for 12 weeks Arms A B and C have intensive PI or NNRTI pharmacokinetic PK sampling at entry and Week 4 All arms have estradiol PK sampling at Week 4 Clinical and laboratory evaluations are done at entry Week 4 and Week 12
ARVs are not provided by this study Only HRT is provided
Patients are enrolled into 1 of 4 study arms based on their current oral ARV regimens Arm A takes NFV plus nucleoside reverse transcriptase inhibitors NRTIs Arm B takes LPVr plus NRTIs Arm C takes EFV plus NRTIs Arm D enrolls HIV-infected patients not on current ARVs or who are taking NRTIs only no protease inhibitors PIs or nonnucleoside reverse transcriptase inhibitors NNRTIs All arms receive HRT with oral estradiol and medroxyprogesterone acetate for 12 weeks Arms A B and C have intensive PI or NNRTI pharmacokinetic PK sampling at entry and Week 4 All arms have estradiol PK sampling at Week 4 Clinical and laboratory evaluations are done at entry Week 4 and Week 12
ARVs are not provided by this study Only HRT is provided
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 A5119 | None | None | None |