Sex, Aging and Antiretroviral Pharmacokinetics
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ClinicalTrials.gov Identifier: NCT00666055 |
Recruitment Status
:
Completed
First Posted
: April 24, 2008
Last Update Posted
: September 20, 2012
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Condition or disease | Intervention/treatment |
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HIV Infections | Drug: ARV regimen chosen by treating physician |
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 Type : | Observational |
Actual Enrollment : | 11 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Group/Cohort | Intervention/treatment |
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Group 1
30 post-menopausal HIV-infected women
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Drug: ARV regimen chosen by treating physician
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). Other Names:
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Group 2
12 pre-menopausal HIV-infected women
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Drug: ARV regimen chosen by treating physician
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). Other Names:
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- To measure and compare steady state blood plasma pharmacokinetics of antiretroviral therapies in post- and pre-menopausal HIV-infected women. [ Time Frame: 6 months ]
- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV-infected women >18 years of age
- There are no specific entry criteria for CD4+ T-cell counts and plasma HIV RNA.
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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.
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666055
United States, North Carolina | |
The University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7215 |
Principal Investigator: | Kristine B Patterson, MD | University of North Carolina, Chapel Hill |
Publications:
Responsible Party: | Kristine Patterson, MD, Clinical Associate Professor, University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00666055 History of Changes |
Other Study ID Numbers: |
CID 0708 1K23AI077355-01 ( U.S. NIH Grant/Contract ) |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | September 20, 2012 |
Last Verified: | September 2012 |
Keywords provided by Kristine Patterson, MD, University of North Carolina, Chapel Hill:
Sex Aging Antiretroviral |
Pharmacokinetics post-menopausal women with HIV infection pre-menopausal women with HIV infection |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir Atazanavir Sulfate |
Tenofovir Lamivudine Raltegravir Potassium Emtricitabine Zidovudine Maraviroc Efavirenz Etravirine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |