Sex, Aging and Antiretroviral Pharmacokinetics
CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599-7215
- The University of North Carolina at Chapel Hill
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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.
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Group 1
30 post-menopausal HIV-infected women
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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).
他の名前:
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Group 2
12 pre-menopausal HIV-infected women
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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).
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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To measure and compare steady state blood plasma pharmacokinetics of antiretroviral therapies in post- and pre-menopausal HIV-infected women.
時間枠:6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
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To longitudinally quantify and compare genital tract antiretroviral drug exposure in post- and pre-menopausal HIV-infected women
時間枠:6 months
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6 months
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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.
時間枠:6 months
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6 months
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協力者と研究者
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
- RNAウイルス感染症
- ウイルス病
- 血液感染症
- 伝染病
- 性感染症、ウイルス
- 性感染症
- レンチウイルス感染症
- レトロウイルス感染症
- 免疫不全症候群
- 免疫系疾患
- 遅いウイルス病
- HIV感染症
- 感染症
- 後天性免疫不全症候群
- 薬理作用の分子機構
- 抗感染剤
- 抗ウイルス剤
- 逆転写酵素阻害剤
- 核酸合成阻害剤
- 酵素阻害剤
- 抗HIV薬
- 抗レトロウイルス剤
- 代謝拮抗剤
- プロテアーゼ阻害剤
- シトクロム P-450 CYP3A 阻害剤
- シトクロム P-450 酵素阻害剤
- シトクロム P-450 酵素誘導剤
- シトクロム P-450 CYP3A インデューサー
- HIV インテグラーゼ阻害剤
- インテグラーゼ阻害剤
- HIVプロテアーゼ阻害剤
- ウイルスプロテアーゼ阻害剤
- シトクロム P-450 CYP2B6 インデューサー
- シトクロム P-450 CYP2C9 阻害剤
- HIV融合阻害剤
- ウイルス融合タンパク質阻害剤
- CCR5受容体拮抗薬
- シトクロム P-450 CYP2C19 阻害剤
- テノホビル
- エムトリシタビン
- ラルテグラビルカリウム
- リトナビル
- ロピナビル
- ラミブジン
- ジドブジン
- マラビロク
- エトラビリン
- 硫酸アタザナビル
- エファビレンツ
その他の研究ID番号
- CID 0708
- 1K23AI077355-01 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集