Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People
A Randomized, Placebo-Controlled, Phase I/II Trial of the Anti-HIV Activity and Safety of VGX-410 (Mifepristone) at Three Dose Levels in HIV-1 Infected Subjects
The purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people.
Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well tolerated.
調査の概要
詳細な説明
Mifepristone is a potent anti-glucocorticoid compound that effectively inhibits replication of both laboratory and clinical HIV isolates in vitro. This study will evaluate the anti-HIV activity and safety of 3 different doses of mifepristone in HIV infected people.
This study will last approximately 2 months. Participants will be randomly assigned to one of 4 study arms, and will receive either mifepristone or placebo daily for 28 days. Arm A participants will receive one of three doses of placebo; Arm B participants will receive 75 mg mifepristone; Arm C participants will receive 150 mg mifepristone; and Arm D participants will receive 225 mg mifepristone. A thorough neck and thyroid examination will be performed within 30 days prior to study entry. Blood collection and vital signs measurement will occur at study entry and Days 3, 7, 14, 21, 28, and 56. Urine collection and pill counts will also be done at some study visits.
研究の種類
入学
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
California
-
Torrance、California、アメリカ、90502-2052
- Harbor-UCLA Med. Ctr. CRS
-
-
District of Columbia
-
Washington、District of Columbia、アメリカ、20007
- Georgetown University CRS (GU CRS)
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455-0392
- University of Minnesota, ACTU
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63108-2138
- Washington U CRS
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27514
- Unc Aids Crs
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- The Ohio State Univ. AIDS CRS
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- Hosp. of the Univ. of Pennsylvania CRS
-
Philadelphia、Pennsylvania、アメリカ、19104
- Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
-
Pittsburgh、Pennsylvania、アメリカ、15213-2582
- Pitt CRS
-
-
Washington
-
Seattle、Washington、アメリカ、98104
- University of Washington AIDS CRS
-
-
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
説明
Inclusion Criteria:
- HIV-1 infected
- CD4 count of 350 cells/mm3 or more within 90 days prior to study entry
- HIV-1 viral load of 2000 copies/ml or more within 90 days prior to study entry
- Willing to use acceptable forms of contraception during the study and for 30 days after stopping study medication
- If currently taking precautionary concomitant medications, must be on stable doses for more than 8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study
- Body weight at least 40 kg (88 lbs) within 90 days prior to study entry
Exclusion Criteria:
- Antiretroviral treatment (ART) within 16 weeks prior to study entry, or intend to start ART within 60 days after entry
- Adrenal disorders
- History of autoimmune endocrine disease in self or family
- History of active hepatitis B or C
- Current treatment for hepatitis B or C
- Moderate to severe liver disease
- Blood disorders or current anticoagulant therapy
- Prior pituitary tumor, surgery, radiation treatment, or pituitary failure
- Moderate to large goiters or thyroid nodules
- Diabetes mellitus
- Unusual uterine bleeding within 12 months prior to study entry
- Current hormonal contraception or intrauterine (IUD) use, including progesterone-containing vaginal rings
- Pregnancy within 90 days prior to study entry
- Breast-feeding
- Drugs that act as inhibitors or inducers of metabolism by cytochrome P450 3A4
- Systemic corticosteroids or hormonal agents within 90 days prior to study entry
- Any immunomodulator, HIV vaccine, or investigational therapy within 90 days prior to study entry
- Any vaccination within 30 days prior to study entry
- Systemic cytotoxic chemotherapy within 90 days prior to study entry
- History of allergy to mifepristone or the study formulations
- Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
- Any other conditions that may interfere with participant evaluation during the study
- Serious illness requiring systemic treatment or hospitalization. Patients who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
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 |
---|
Changes in HIV-1 viral load from baseline to Days 14 and 28
|
二次結果の測定
結果測定 |
---|
Within 28 days on study, occurrence of toxicity, rash, and symptoms of adrenal insufficiency, including fatigue, nausea, anorexia, vomiting, and dizziness
|
changes from baseline viral load on Days 7, 14, 21, 28, and 56
|
pre-dose concentrations of mifepristone on Days 14 and 28 and serum level of alpha-1 acidic glycoprotein (AAG) at Day 0
|
percentage and counts of CD4 and CD8 cells at baseline and on Days 14, 28, and 56
|
Vpr amino acid sequences on Days 0, 14, 28, and 56
|
comparison of the magnitude and diversity of effector T cell response to HIV antigens at Days 0, 28, and 56
|
change in fasting concentrations of plasma insulin, free fatty acids, high-density lipoprotein (HDL) cholesterol and triglycerides, and in insulin sensitivity between Days 0 and 28
|
協力者と研究者
捜査官
- スタディチェア:Michael F. Para, MD、Ohio State University
出版物と役立つリンク
一般刊行物
- Schafer E, Wagner M, and Ayyavoo V. Antiviral Effects of Mifepristone and its Analogs on HIV-1 Vpr-Induced Virus Replication. 11th Conference on Retroviruses and Opportunistic Infections. February 2004.
- Ayyavoo V, Mahboubi A, Mahalingam S, Ramalingam R, Kudchodkar S, Williams WV, Green DR, Weiner DB. HIV-1 Vpr suppresses immune activation and apoptosis through regulation of nuclear factor kappa B. Nat Med. 1997 Oct;3(10):1117-23. doi: 10.1038/nm1097-1117.
- Para MF, Schouten J, Rosenkranz SL, Yu S, Weiner D, Tebas P, White CJ, Reeds D, Lertora J, Patterson KB, Daar ES, Cavert W, Brizz B; ACTG A5200 Team of the ACTG. Phase I/II trial of the anti-HIV activity of mifepristone in HIV-infected subjects ACTG 5200. J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):491-5. doi: 10.1097/QAI.0b013e3181d142cb.
研究記録日
主要日程の研究
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- A5200
- 10186 (その他の識別子:CTEP)
- ACTG A5200
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
-
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
-
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
-
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
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
-
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
-
Erasmus Medical Centerまだ募集していません
-
University of Maryland, Baltimore引きこもった
-
Hospital Clinic of Barcelona完了
-
University of WashingtonNational Institute of Mental Health (NIMH)募集