HIV InfectionsPhase 1NCT00044837
Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women
A Phase 1 study testing Medroxyprogesterone acetate and Estradiol in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Medroxyprogesterone acetate and Estradiol
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are postmenopausal women over 18 years old.
- Are infected with HIV.
- Have a CD4 cell count of 100 cells/mm3 or greater within 45 days prior to study entry.
- Have a plasma viral load less than 55,000 copies/ml within 45 days prior to study entry.
- Are willing to comply with study requirements. These include not changing smoking habits during the course of the study and not consuming caffeine or alcohol prior to PK sampling.
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- Have had a Pap smear within 12 months prior to study entry.
- Meet one of the following requirements: a) patients must currently be on stable PI or EFV regimens plus 2 or more acceptable NRTIs, or b) patients must not currently be taking any ARVs, with the exception of an NRTI-only regimen.
- Have a way to obtain their ARVs outside of the study and agree to continue their ARV regimen for at least 12 weeks of the study.
Who cannot join
- Patients may not be eligible for this study if they:
- Have had breast or endometrial cancer, thrombophlebitis, or thromboembolism.
- Have had serious nausea, vomiting, or abdominal pain within 30 days prior to study entry.
- Have had a serious illness requiring systemic treatment and/or hospitalization within 14 days prior to study entry.
- Are allergic or sensitive to the drugs that will be used for HRT.
- Have undiagnosed postmenopausal bleeding.
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- Have coronary artery disease.
- Have used hormonal therapies within 8 weeks prior to study entry.
- Have used DMPA (Depo Provera) within 180 days prior to study entry.
- Have used the anti-HIV drugs ZDV and d4T at the same time within 30 days prior to study entry.
- Have used other medications specified in the protocol within 30 days prior to study entry.
- Are using experimental drugs without the written approval of the study co-chairs.
- Are unable to adhere to the ARV or HRT medications while on study, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- HIV Infections
- Being tested
- Medroxyprogesterone acetate, Estradiol
- Keywords
- Lopinavir, HIV-1, HIV Protease Inhibitors, Ritonavir, Postmenopause, Reverse Transcriptase Inhibitors, Pharmacokinetics, Area Under Curve, Hormone Replacement Therapy, efavirenz, estradiol
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone acetateDrug
EstradiolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Lori Kamemoto, Study chairMary Vogler, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044837
- Sponsor's protocol ID
- ACTG A5119
- Other IDs
- AACTG A5119
- Status last verified
- Jun 2003
- First submitted
- 5 Sep 2002
- Last updated
- 4 Jun 2015
- Results posted
- No
Publications
Clark RA, Cohn SE, Jarek C, Craven KS, Lyons C, Jacobson M, Kamemoto L. Perimenopausal symptomatology among HIV-infected women at least 40 years of age. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):99-100. doi: 10.1097/00126334-200001010-00016. No abstract available.
PubMed 10708064Gorski JC, Wang Z, Haehner-Daniels BD, Wrighton SA, Hall SD. The effect of hormone replacement therapy on CYP3A activity. Clin Pharmacol Ther. 2000 Oct;68(4):412-7. doi: 10.1067/mcp.2000.110560.
PubMed 11061581Porter VR, Greendale GA, Schocken M, Zhu X, Effros RB. Immune effects of hormone replacement therapy in post-menopausal women. Exp Gerontol. 2001 Feb;36(2):311-26. doi: 10.1016/s0531-5565(00)00195-9.
PubMed 11226745Ouellet D, Hsu A, Qian J, Locke CS, Eason CJ, Cavanaugh JH, Leonard JM, Granneman GR. Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br J Clin Pharmacol. 1998 Aug;46(2):111-6. doi: 10.1046/j.1365-2125.1998.00749.x.
PubMed 9723818
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Pharmacokinetic Study of Hormone Replacement Therapy in HIV-1-Infected, Postmenopausal Women on Nelfinavir, Lopinavir/Ritonavir, or Efavirenz
- ClinicalTrials.gov ID
- NCT00044837
- Acronym / sponsor ID
- ACTG A5119
- Conditions
- HIV Infections
- Keywords
- Lopinavir, HIV-1, HIV Protease Inhibitors, Ritonavir, Postmenopause, Reverse Transcriptase Inhibitors, Pharmacokinetics, Area Under Curve
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 9 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are postmenopausal women over 18 years old.
- Are infected with HIV.
- Have a CD4 cell count of 100 cells/mm3 or greater within 45 days prior to study entry.
- Have a plasma viral load less than 55,000 copies/ml within 45 days prior to study entry.
- Are willing to comply with study requirements. These include not changing smoking habits during the course of the study and not consuming caffeine or alcohol prior to PK sampling.
Key exclusion criteria (13 listed)
- Have had breast or endometrial cancer, thrombophlebitis, or thromboembolism.
- Have had serious nausea, vomiting, or abdominal pain within 30 days prior to study entry.
- Have had a serious illness requiring systemic treatment and/or hospitalization within 14 days prior to study entry.
- Are allergic or sensitive to the drugs that will be used for HRT.
- Have undiagnosed postmenopausal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medroxyprogesterone acetate | Drug | – |
| Estradiol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 10708064Clark RA, Cohn SE, Jarek C, Craven KS, Lyons C, Jacobson M, Kamemoto L. Perimenopausal symptomatology among HIV-infected women at least 40 years of age. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):99-100. doi: 10.1097/00126334-200001010-00016. No abstract available.
- Background: PubMed 11061581Gorski JC, Wang Z, Haehner-Daniels BD, Wrighton SA, Hall SD. The effect of hormone replacement therapy on CYP3A activity. Clin Pharmacol Ther. 2000 Oct;68(4):412-7. doi: 10.1067/mcp.2000.110560.
- Background: PubMed 11226745Porter VR, Greendale GA, Schocken M, Zhu X, Effros RB. Immune effects of hormone replacement therapy in post-menopausal women. Exp Gerontol. 2001 Feb;36(2):311-26. doi: 10.1016/s0531-5565(00)00195-9.
- Background: PubMed 9723818Ouellet D, Hsu A, Qian J, Locke CS, Eason CJ, Cavanaugh JH, Leonard JM, Granneman GR. Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br J Clin Pharmacol. 1998 Aug;46(2):111-6. doi: 10.1046/j.1365-2125.1998.00749.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Kamemoto study chair
Mary Vogler study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medroxyprogesterone acetate and Estradiol in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044837, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.