Antiretroviral Therapy for Acute HIV Infection
調査の概要
詳細な説明
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Kampala、ウガンダ
- Makerere University--Walter Reed Project (MUWRP)
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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
説明
Inclusion Criteria:
- First identified as an incident HIV infection within one year of estimated time of infection in RV 217.
- Willing to begin Genvoya® as soon as entering this study but not later than 7 days from study enrollment.
- Successfully passed Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts.
- Adult from 18 to 50 years of age.
- Able to participate for 96 weeks of study visits
- In general good health as determined by the PI or his/her designee
- Willing to have photo or fingerprint taken for identification purposes
- No history of ART for any reason, i.e., treatment naïve and no HIV-post-exposure prophylaxis (PEP) or HIV-pre-exposure prophylaxis (PrEP)) within 90 days prior to enrollment
- Willing to have blood samples collected and stored.
- Adequate renal function: estimated creatine clearance of >50 mL/min according to the Cockroft Gault formula 2 weeks prior to enrollment
- Urine clean catch: glucose < trace and protein <1+ or as per site-specification 2 weeks prior to enrollment
- Weight is > 35 kg
- Female (only women of childbearing potential) Specific Criteria:
Negative pregnancy test 48 hours prior to enrollment:
Commits to continued use of adequate birth control method for 96 weeks of the study and prior to receiving study ART. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence. If depending on hormonal contraception, check package insert for drug interactions and/or consider adding a second barrier method.
Exclusion Criteria:
- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including but not limited to chronic hepatitis, renal insufficiency or failure; clinically significant forms of drug or alcohol abuse, mental illness, severe asthma, psychiatric disorders, heart disease, or cancer; or a physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit, etc.
- Untreated AIDS-related opportunistic infection
- An AIDS defining condition diagnosed within 30 days
- Positive Hepatitis B surface antigen at any time in the past
- Requiring use of any medication that is contraindicated with Genvoya®. See Appendix I and the package insert
- Women who are breast-feeding
There are no inclusion/exclusion criteria based on CD4 count because CD4 count can be transiently diminished during acute HIV infection and ART initiation during early or acute HIV infection offers the potential benefit of limiting reservoir seeding and preventing immune destruction regardless of peripheral CD4 count at the time of treatment initiation.
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment.
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Participants will receive 1 tablet per day throughout study duration (96 weeks).
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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 |
メジャーの説明 |
時間枠 |
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Plasma viral load
時間枠:Measured at 48 weeks after enrollment
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The number of study participants with plasma viral load <50 copies/mL
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Measured at 48 weeks after enrollment
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Plasma viral load
時間枠:Measured at 96 weeks after enrollment
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The number of study participants with plasma viral load <50 copies/mL
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Measured at 96 weeks after enrollment
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Drug-related AEs and SAEs
時間枠:Measured through week 96
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Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
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Measured through week 96
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Treatment Discontinuation for AEs up to 96 weeks
時間枠:Measured through week 96
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Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
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Measured through week 96
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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CD4+ T cell count change
時間枠:Measured over 48 weeks
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CD4+ T cell count change over first 48 weeks as compared to baseline.following
the initiation of Genvoya®
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Measured over 48 weeks
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Frequency of HIV-related illnesses
時間枠:Measured through week 96
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Frequency of HIV-related illnesses (including acute retroviral syndrome)
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Measured through week 96
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Duration of HIV-related illnesses
時間枠:Measured through week 96
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Duration of HIV-related illnesses (including acute retroviral syndrome)
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Measured through week 96
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Changes in HIV-specific immune responses over time
時間枠:Measured through week 96
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Description of changes in HIV-specific immune responses over time as characterized by intracellular cytokine staining (ICS)
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Measured through week 96
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Host humoral (IgG) responses
時間枠:Measured through week 96
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Characterization of evolution in host humoral (IgG) responses to HIV envelope over time including development of neutralizing antibody responses
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Measured through week 96
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Markers of Immune Activation
時間枠:Measured through week 96
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Description of markers of immune activation (soluble and cellular markers) by ICS.
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Measured through week 96
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HIV reservoir size
時間枠:Measured through week 96
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Evaluation of the HIV reservoir size by measurement of 1) single copy HIV RNA quantification in samples with HIV RNA <50 copies/mL and 2) total HIV DNA and integrated HIV DNA in peripheral blood
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Measured through week 96
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Neuropsychological battery performance
時間枠:Measured through week 96
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Evaluation of neuropsychological battery performance at week 48 and 96; and to later compare to RV 217 data from pre-infection and baseline early or acute HIV infection timepoints.
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Measured through week 96
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協力者と研究者
協力者
捜査官
- スタディチェア:Christina Polyak, MD, MPH、Henry M. Jackson Foundation in support of MHRP
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
- RV 392
- WRAIR 2393 (その他の識別子:WRAIR)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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
Genvoya 150Mg-150Mg-200Mg-10Mg Tabletの臨床試験
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Janssen Scientific Affairs, LLC完了
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Chengdu Zenitar Biomedical Technology Co., Ltd募集
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.わからない
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Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG Oncology; Eastern Cooperative Oncology Group; North Central...完了
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IRCCS San RaffaeleGilead Sciences終了しました
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University of Southern CaliforniaNational Cancer Institute (NCI)募集癌 | 転移性 | 胸 | トリプルネガティブ | 播種性腫瘍細胞アメリカ