臨床研究等提出・公開システム

国立研究開発法人国立国際医療研究センター病院

Center Hospital of the National Center for Global Health and Medicine

独立行政法人国立病院機構　名古屋医療センター

National Hospital Organization Ngoya Medical Center

独立行政法人国立病院機構　大阪医療センター

National Hospital Organization Osaka National Hospital

無作為化比較 非盲検 実薬(治療)対照 並行群間比較

randomized controlled trial open(masking not used) active control parallel assignment

1. 同意説明文書に署名する時点で18歳以上であるHIV-1に感染しART未治療の男女。
2. スクリーニング時の血漿中HIV-1 RNA量1000 c/mL以上により確認されたHIV-1感染。
3. 抗レトロウイルス薬未治療（HIV-1感染の診断後、何らかの抗レトロウイルス薬による前治療が10日以内）。1回でもHIV INSTI又はNNRTIの投与歴がある場合は除外する。
4. 女性被験者は妊娠していない及び授乳していない、並びに少なくとも以下の一つに該当する女性
a. 妊娠の可能性のない女性
b. 妊娠の可能性がある女性の場合、治験薬の初回投与の30日前から全治験期間、及びすべての経口治験薬中止後少なくとも30日間、治験薬注射剤の投与中止後少なくとも 52週間は、極めて有効な避妊法の一つを遵守することに合意する。

1. HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent.
2. HIV-1 infection as documented by Screening plasma HIV-1 RNA >- 1000 c/mL
3. Antiretroviral-naive (<-10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.
4. A female participant is eligible to participate if she is not pregnant or not lactating, and at least one of the following conditions applies:
a. Non-reproductive potential
b. Reproductive potential and agrees to follow one of Highly Effective Methods for Avoiding Pregnancy from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of all injectable study medications.

1. 妊娠している女性、授乳中の女性、又は本治験期間中に妊娠又は授乳する予定がある女性。
2. スクリーニング時において活動性の米国疾病対策予防センター（CDC）ステージ3の疾患の所見。ただし、全身療法の必要のない、又は過去もしくは現在のCD4陽性細胞数が200 /mm3未満の皮膚カポジ肉腫は除外しない。
3. 中等度から重度の肝障害を有する患者。
4. スクリーニング時のB型肝炎表面抗原（HBs抗原）、B型肝炎コア抗体（HBc抗体）、B型肝炎表面抗体（HBs抗体）、及びHBV DNA検査に基づくB型肝炎ウイルス（HBV）感染所見：
　　・HBs 抗原陽性患者は除外する。
　　・HBs 抗体は陰性だがHBc 抗体陽性（HBs 抗原陰性）及びHBV DNA 陽性の患者は除外する。
注意：HBc 抗体陽性（HBs 抗原陰性）及びHBs 抗体陽性（過去又は現在の感染を示
す）の患者はHBV に対する免疫があり、除外しない。
5. 肝炎ウイルスの重複感染の有無に関わらず肝硬変の既往。
6. 進行中又は臨床的に関連のある膵炎。
7. 全患者に梅毒のスクリーニング［血漿レアギン迅速試験（RPR）］を行う。RPR 陽性で明確な治療歴がないと定義される未治療の梅毒感染者は除外する。治療を受けたことのないPRP 陽性の患者は梅毒の抗菌薬治療完了の30 日以上後に再スクリーニングをしてもよい。
8. 皮膚カポジ肉腫、基底細胞癌、切除済みの非浸潤性皮膚扁平上皮癌、又は子宮頸部、肛門、陰茎上皮内腫瘍を除く進行中の悪性腫瘍。その他の限局性悪性腫瘍については、登録の前に患者の適格性に関して治験責任（分担）医師とメディカルモニターとで合意する必要がある。
9. NNRTIに対する初期耐性（認められているK103Nを除く）の所見、又は過去の耐性検査により判明しているINSTIに対する耐性（International AIDS Society［IAS］-USA,2015）。注意：スクリーニングの遺伝子型再検査は当該治験のウイルス学者が判断した場合のみ認められる。
10. HLA-B* 5701陽性、及びアバカビルを含まないNRTI がバックボーンとして使用できない患者（HLA-B*5701 陽性であってもアバカビルを含まないNRTI をバックボーンとして使用できるのであれば登録してよい。NRTI の代替薬を提供できない国においては、HLA-B*5701 陽性患者を除外する場合もある。）。

1. Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
2. Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease , except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
3. Participants with known moderate to severe hepatic impairment.
4. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows
-Participants positive for HBsAg are excluded;
-Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded
5. History of liver cirrhosis with or without hepatitis viral co-infection.
6. Ongoing or clinically relevant pancreatitis.
7. All participants will be screened for syphilis (rapid plasma reagin [RPR]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis.
8. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrolment.
9. Any evidence of primary resistance to NNRTIs (except for K103N which is allowed), or any known resistance to INIs from historical resistance test results (International AIDS Society [ IAS]-USA, 2015). Note: Re-tests of Screening genotypes are allowed only at the discretion of the study virologist.
10. Participants who are HLA-B*5701 positive and are unable to use an NRTI backbone that does not contain abacavir (participants who are HLA-B*5701 positive may be enrolled if they use a NRTI backbone that does not contain abacavir; HLA-B*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not1. Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
2. Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease , except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
3. Participants with known moderate to severe hepatic impairment.
4. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows
-Participants positive for HBsAg are excluded;
-Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded
5. History of liver cirrhosis with or without hepatitis viral co-infection.
6. Ongoing or clinically relevant pancreatitis.
7. All participants will be screened for syphilis (rapid plasma reagin [RPR]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis.
8. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrolment.
9. Any evidence of primary resistance to NNRTIs (except for K103N which is allowed), or any known resistance to INIs from historical resistance test results (International AIDS Society [ IAS]-USA, 2015). Note: Re-tests of Screening genotypes are allowed only at the discretion of the study virologist.
10. Participants who are HLA-B*5701 positive and are unable to use an NRTI backbone that does not contain abacavir (participants who are HLA-B*5701 positive may be enrolled if they use a NRTI backbone that does not contain abacavir; HLA-B*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not possible).

18歳以上

18age old over

上限なし

No limit

男性・女性

Both

実施中

progressing