HIV InfectionsNCT00666055
Sex, Aging and Antiretroviral Pharmacokinetics
An observational study of HIV Infections, run by Kristine Patterson, MD at 1 site in United States.
Trial summary
The purpose of this research study is to learn about levels of antiretroviral drug levels and response to HIV virus in the genital tract of women who are post-menopausal. The investigators in this study think that the levels of hormones post-menopausal HIV-infected women may have in their bodies may affect the levels… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- ARV regimen chosen by treating physician
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2012
- Phase
- Observational
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will primarily be recruited from the UNC Infectious Disease Clinic and the Wake County HIV Clinic.
Who may be able to join
- HIV-infected women >18 years of age
- There are no specific entry criteria for CD4+ T-cell counts and plasma HIV RNA.
- Menopause status will be determined at screening.
- Post-menopausal will be defined as the cessation of menses for >12 months (or undergone a bilateral oophorectomy with or without a hysterectomy) AND a FSH >25 miu/mL and estradiol level <20 pg/mL establishing both physiological and biochemical evidence of menopause.
- Pre-menopausal women must have regular cycles without peri-menopausal vasomotor symptoms and not receiving exogenous hormones.
- Women may be changing to a new regimen because of virologic failure or intolerability. Women in whom resistance testing is available, two or more drugs to which the virus is susceptible needs to be included in the proposed treatment regimen.
Show all 11Show fewer
- Women may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir).
- Provided the ARV regimens contain one or more of the agents under study they may also include new agents such as maraviroc (CCR5 inhibitor), raltegravir (integrase inhibitor) and/or etravirine (NNRTI). Samples will be stored so that the pharmacokinetics of these agents can be evaluated in future studies once the assays are available in our lab.
- Women must be free from sexually transmitted infections (STI's) at the time of enrollment.
- Women must be able to abstain from douching and sexual activity for 72 hours prior to all study visits.
- Subjects must be willing to have genital tract samples taken.
Who cannot join
- Women currently receiving medication with known drug-drug interaction with the ARVs under study.
- Women currently receiving any exogenous hormone therapy (contraception, estrogen replacement therapy or androgen supplements). Women must be off all exogenous hormone therapy for > 16 weeks prior to enrollment.
- Women who are pregnant or breast-feeding.
- Women with a hemoglobin <9.0g/dL and/or hematocrit <28%.
- Women unable to complete, or have a caretaker complete, a dose administration card.
- Women who, in the judgement of the investigator, are unable to comply with the protocol requirements.
Show all 9Show fewer
- Women who are unable to give written informed consent.
- Women who cannot comply with abstaining from intercourse or douching 48 hours prior to study examination.
- Male or transgender individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7215
About this study
Official title: CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics
The purpose of this research study is to learn about levels of antiretroviral drug levels and response to HIV virus in the genital tract of women who are post-menopausal. The investigators in this study think that the levels of hormones post-menopausal HIV-infected women may have in their bodies may affect the levels of antiretroviral drug, and therefore affect how much HIV virus they have in their bodies. Since women who have already gone through menopause have different levels of hormones, such as estrogen, than women who are pre-menopausal, the investigators would like to check the levels of antiretroviral drugs in their blood, their genital secretions, and their genital tissue.
Read the detailed description
Purpose: To longitudinally quantify systemic and genital tract antiretroviral pharmacokinetics and viral responses in HIV-infected post-menopausal women. These parameters will be compared to pre-menopausal women to determine if the absence or presence of estrogen influences treatment responses and infectiousness of HIV.
Participants: 30 post-menopausal and 12 pre-menopausal HIV-infected women Procedures (methods): First dose, steady state, and longitudinal pharmacokinetics of the most commonly prescribed antiretroviral agents will be assessed in the systemic and genital tract compartments in a cohort of post- and pre-menopausal HIV-infected women. Concurrent blood plasma and genital secretions HIV RNA will be measured. Systemic and genital tract virologic responses will be correlated with antiretroviral concentrations and with each other.
- Conditions
- HIV Infections
- Being tested
- ARV regimen chosen by treating physician
- Keywords
- Sex, Aging, Antiretroviral, Pharmacokinetics, post-menopausal women with HIV infection, pre-menopausal women with HIV infection
- Medical subject headings
- HIV Infections, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARV regimen chosen by treating physicianDrug
Also called Zidovudine: ZDV, Retrovir, Retrovis, AZT (Azidothymidine), Lamivudine: 3TC, Zeffix, Epivir, Epivir-HBV, Emtricitabine: FTC, Emtriva, Abacivir: Ziagen
Women may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir).
Provided the ARV regimens contain one or more of the agents under study they may also include new agents such as maraviroc (CCR5 inhibitor), raltegravir (integrase inhibitor) and/or etravirine (NNRTI).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 30 post-menopausal HIV-infected women Receives: Drug: ARV regimen chosen by treating physician | |
| Group 2 | 12 pre-menopausal HIV-infected women Receives: Drug: ARV regimen chosen by treating physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure and compare steady state blood plasma pharmacokinetics of antiretroviral therapies in post- and pre-menopausal HIV-infected women.
Measured: 6 months
Secondary outcomes (2)
To longitudinally quantify and compare genital tract antiretroviral drug exposure in post- and pre-menopausal HIV-infected women
Measured: 6 months
To determine and compare sexual HIV infectivity in post- and pre-menopausal HIV-infected women by measuring HIV RNA dynamics in blood plasma and genital tract secretions before and after the initiation of highly active antiretroviral therapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (109)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristine Patterson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristine Patterson, MD, University of North Carolina, Chapel Hill
- Investigators
- Kristine B Patterson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666055
- Sponsor's protocol ID
- CID 0708
- Other IDs
- 1K23AI077355-01
- Status last verified
- Sep 2012
- First submitted
- 22 Apr 2008
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gruber CJ, Tschugguel W, Schneeberger C, Huber JC. Production and actions of estrogens. N Engl J Med. 2002 Jan 31;346(5):340-52. doi: 10.1056/NEJMra000471. No abstract available.
PubMed 11821512Burger HG, Dudley E, Mamers P, Robertson D, Groome N, Dennerstein L. The ageing female reproductive axis I. Novartis Found Symp. 2002;242:161-7; discussion 167-71.
PubMed 11855686Gracia CR, Sammel MD, Freeman EW, Lin H, Langan E, Kapoor S, Nelson DB. Defining menopause status: creation of a new definition to identify the early changes of the menopausal transition. Menopause. 2005 Mar;12(2):128-35. doi: 10.1097/00042192-200512020-00005.
PubMed 15772558Landgren BM, Collins A, Csemiczky G, Burger HG, Baksheev L, Robertson DM. Menopause transition: Annual changes in serum hormonal patterns over the menstrual cycle in women during a nine-year period prior to menopause. J Clin Endocrinol Metab. 2004 Jun;89(6):2763-9. doi: 10.1210/jc.2003-030824.
PubMed 15181055Burger HG, Dudley EC, Robertson DM, Dennerstein L. Hormonal changes in the menopause transition. Recent Prog Horm Res. 2002;57:257-75. doi: 10.1210/rp.57.1.257.
PubMed 12017547Gracia CR, Freeman EW. Acute consequences of the menopausal transition: the rise of common menopausal symptoms. Endocrinol Metab Clin North Am. 2004 Dec;33(4):675-89. doi: 10.1016/j.ecl.2004.07.003.
PubMed 15501640Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
PubMed 12117397CDC HIV/AIDS Surveillance Report 2005. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/index.htm#surveillance. Accessed March 8, 2007.
Pilcher CD, Eron JJ Jr, Vemazza PL, Battegay M, Harr T, Yerly S, Vom S, Perrin L. Sexual transmission during the incubation period of primary HIV infection. JAMA. 2001 Oct 10;286(14):1713-4. doi: 10.1001/jama.286.14.1713. No abstract available.
PubMed 11594895Pedraza MA, del Romero J, Roldan F, Garcia S, Ayerbe MC, Noriega AR, Alcami J. Heterosexual transmission of HIV-1 is associated with high plasma viral load levels and a positive viral isolation in the infected partner. J Acquir Immune Defic Syndr. 1999 Jun 1;21(2):120-5.
PubMed 10360803Ragni MV, Faruki H, Kingsley LA. Heterosexual HIV-1 transmission and viral load in hemophilic patients. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Jan 1;17(1):42-5. doi: 10.1097/00042560-199801010-00006.
PubMed 9436757Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000 Mar 30;342(13):921-9. doi: 10.1056/NEJM200003303421303.
PubMed 10738050Chakraborty H, Sen PK, Helms RW, Vernazza PL, Fiscus SA, Eron JJ, Patterson BK, Coombs RW, Krieger JN, Cohen MS. Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: a probabilistic empiric model. AIDS. 2001 Mar 30;15(5):621-7. doi: 10.1097/00002030-200103300-00012.
PubMed 11317000Royce RA, Sena A, Cates W Jr, Cohen MS. Sexual transmission of HIV. N Engl J Med. 1997 Apr 10;336(15):1072-8. doi: 10.1056/NEJM199704103361507. No abstract available.
PubMed 9091805Mofenson LM, Lambert JS, Stiehm ER, Bethel J, Meyer WA 3rd, Whitehouse J, Moye J Jr, Reichelderfer P, Harris DR, Fowler MG, Mathieson BJ, Nemo GJ. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. Pediatric AIDS Clinical Trials Group Study 185 Team. N Engl J Med. 1999 Aug 5;341(6):385-93. doi: 10.1056/NEJM199908053410601.
PubMed 10432323
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics
- ClinicalTrials.gov ID
- NCT00666055
- Acronym / sponsor ID
- CID 0708
- Conditions
- HIV Infections
- Keywords
- Sex, Aging, Antiretroviral, Pharmacokinetics, post-menopausal women with HIV infection, pre-menopausal women with HIV infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kristine Patterson, MDUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Apr 2008 (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 research study is to learn about levels of antiretroviral drug levels and response to HIV virus in the genital tract of women who are post-menopausal. The investigators in this study think that the levels of hormones post-menopausal HIV-infected women may have in their bodies may affect the levels of antiretroviral drug, and therefore affect how much HIV virus they have in their bodies. Since women who have already gone through menopause have different levels of hormones, such as estrogen, than women who are pre-menopausal, the investigators would like to check the levels of antiretroviral drugs in their blood, their genital secretions, and their genital tissue.
Detailed description
Purpose: To longitudinally quantify systemic and genital tract antiretroviral pharmacokinetics and viral responses in HIV-infected post-menopausal women. These parameters will be compared to pre-menopausal women to determine if the absence or presence of estrogen influences treatment responses and infectiousness of HIV.
Participants: 30 post-menopausal and 12 pre-menopausal HIV-infected women Procedures (methods): First dose, steady state, and longitudinal pharmacokinetics of the most commonly prescribed antiretroviral agents will be assessed in the systemic and genital tract compartments in a cohort of post- and pre-menopausal HIV-infected women. Concurrent blood plasma and genital secretions HIV RNA will be measured. Systemic and genital tract virologic responses will be correlated with antiretroviral concentrations and with each other.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: ARV regimen chosen by treating physician30 post-menopausal HIV-infected women |
| Group 2 | – | Drug: ARV regimen chosen by treating physician12 pre-menopausal HIV-infected women |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will primarily be recruited from the UNC Infectious Disease Clinic and the Wake County HIV Clinic.
Key inclusion criteria (11 listed)
- HIV-infected women >18 years of age
- There are no specific entry criteria for CD4+ T-cell counts and plasma HIV RNA.
- Menopause status will be determined at screening.
- Women may be changing to a new regimen because of virologic failure or intolerability. Women in whom resistance testing is available, two or more drugs to which the virus is susceptible needs to be included in the proposed treatment regimen.
- Women may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir).
Key exclusion criteria (9 listed)
- Women currently receiving medication with known drug-drug interaction with the ARVs under study.
- Women currently receiving any exogenous hormone therapy (contraception, estrogen replacement therapy or androgen supplements). Women must be off all exogenous hormone therapy for > 16 weeks prior to enrollment.
- Women who are pregnant or breast-feeding.
- Women with a hemoglobin <9.0g/dL and/or hematocrit <28%.
- Women unable to complete, or have a caretaker complete, a dose administration card.
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 |
|---|---|---|
| ARV regimen chosen by treating physicianAlso: Zidovudine: ZDV, Retrovir, Retrovis, AZT (Azidothymidine), Lamivudine: 3TC, Zeffix, Epivir, Epivir-HBV, Emtricitabine: FTC, Emtriva, Abacivir: ZiagenWomen may also be naïve to either NNRTI or PIs and initiating their first, second or third HAART regimen (ARVs to be investigated: zidovudine, lamivudine, emtricitabine, abacavir, tenofovir, efavirenz, lopinavir/ritonavir, atazanavir with or without ritonavir). Provided the ARV regimens contain one or more of the agents under study they may also include new agents such as maraviroc (CCR5 inhibitor), raltegravir (integrase inhibitor) and/or etravirine (NNRTI). | Drug | Group 1, Group 2 |
Primary outcome
To measure and compare steady state blood plasma pharmacokinetics of antiretroviral therapies in post- and pre-menopausal HIV-infected women.
Time frame: 6 months
2 secondary outcomes
To longitudinally quantify and compare genital tract antiretroviral drug exposure in post- and pre-menopausal HIV-infected women
Time frame: 6 months
To determine and compare sexual HIV infectivity in post- and pre-menopausal HIV-infected women by measuring HIV RNA dynamics in blood plasma and genital tract secretions before and after the initiation of highly active antiretroviral therapy.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Background: PubMed 11821512Gruber CJ, Tschugguel W, Schneeberger C, Huber JC. Production and actions of estrogens. N Engl J Med. 2002 Jan 31;346(5):340-52. doi: 10.1056/NEJMra000471. No abstract available.
- Background: PubMed 11855686Burger HG, Dudley E, Mamers P, Robertson D, Groome N, Dennerstein L. The ageing female reproductive axis I. Novartis Found Symp. 2002;242:161-7; discussion 167-71.
- Background: PubMed 15772558Gracia CR, Sammel MD, Freeman EW, Lin H, Langan E, Kapoor S, Nelson DB. Defining menopause status: creation of a new definition to identify the early changes of the menopausal transition. Menopause. 2005 Mar;12(2):128-35. doi: 10.1097/00042192-200512020-00005.
- Background: PubMed 15181055Landgren BM, Collins A, Csemiczky G, Burger HG, Baksheev L, Robertson DM. Menopause transition: Annual changes in serum hormonal patterns over the menstrual cycle in women during a nine-year period prior to menopause. J Clin Endocrinol Metab. 2004 Jun;89(6):2763-9. doi: 10.1210/jc.2003-030824.
- Background: PubMed 12017547Burger HG, Dudley EC, Robertson DM, Dennerstein L. Hormonal changes in the menopause transition. Recent Prog Horm Res. 2002;57:257-75. doi: 10.1210/rp.57.1.257.
- Background: PubMed 15501640Gracia CR, Freeman EW. Acute consequences of the menopausal transition: the rise of common menopausal symptoms. Endocrinol Metab Clin North Am. 2004 Dec;33(4):675-89. doi: 10.1016/j.ecl.2004.07.003.
- Background: PubMed 12117397Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
- BackgroundCDC HIV/AIDS Surveillance Report 2005. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/index.htm#surveillance. Accessed March 8, 2007.
- Background: PubMed 11594895Pilcher CD, Eron JJ Jr, Vemazza PL, Battegay M, Harr T, Yerly S, Vom S, Perrin L. Sexual transmission during the incubation period of primary HIV infection. JAMA. 2001 Oct 10;286(14):1713-4. doi: 10.1001/jama.286.14.1713. No abstract available.
- Background: PubMed 10360803Pedraza MA, del Romero J, Roldan F, Garcia S, Ayerbe MC, Noriega AR, Alcami J. Heterosexual transmission of HIV-1 is associated with high plasma viral load levels and a positive viral isolation in the infected partner. J Acquir Immune Defic Syndr. 1999 Jun 1;21(2):120-5.
- Background: PubMed 9436757Ragni MV, Faruki H, Kingsley LA. Heterosexual HIV-1 transmission and viral load in hemophilic patients. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Jan 1;17(1):42-5. doi: 10.1097/00042560-199801010-00006.
- Background: PubMed 10738050Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med. 2000 Mar 30;342(13):921-9. doi: 10.1056/NEJM200003303421303.
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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.
Kristine B Patterson, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Kristine Patterson, MD 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 20 Sep 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To measure and compare steady state blood plasma pharmacokinetics of antiretroviral therapies in post- and pre-menopausal HIV-infected women. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666055, which also lists 109 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 20 Sep 2012.