HIV Infections Clinical Trial
Official title:
A Phase I, Pharmacokinetic Study of Hormone Replacement Therapy in HIV-1-Infected, Postmenopausal Women on Nelfinavir, Lopinavir/Ritonavir, or Efavirenz
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
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