Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women
The purpose of this study is to find out if the anti-HIV drugs nelfinavir (NFV), lopinavir/ritonavir (LPV/r), 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.
Drug: Medroxyprogesterone acetate
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
|Official Title:||A Phase I, Pharmacokinetic Study of Hormone Replacement Therapy in HIV-1-Infected, Postmenopausal Women on Nelfinavir, Lopinavir/Ritonavir, or Efavirenz|
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 Alzheimer's 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 LPV/r 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044837
|United States, Maryland|
|Rockville, Maryland, United States, 20852|
|Study Chair:||Lori Kamemoto|
|Study Chair:||Mary Vogler|