Safety and Efficacy of Raltegravir+TDF+3TC in HBV/HIV Co-infected Patients
A Randomized, Pilot Estimation Study to Compare the Safety and Efficacy of Raltegravir+TDF+3TC Versus TDF+3TC+EFV in HBV/HIV Co-infected Patients
調査の概要
状態
詳細な説明
There are in total more than 72939 HIV infected people reported in Yunnan, the largest number for any province in China. About 800 HIV inpatients are admitted to our hospital every year, amongst them about 10% co-infected with HBV. HIV and HBV co-infection patients must receive two drugs active against both HIV and HBV, for example Tenofovir disoproxil fumarate (TDF)+ lamivudine (3TC) or TDF+FTC. TDF and 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases (Dore, Cooper et al. 2004). Combination therapy could decrease drug resistance. In China, TDF is a second-line drug of the national free ART program; however FTC is not in the list of free drugs. There is likely higher risk of causing drug resistance in treating HBV or HIV infection with 3TC or TDF monotherapy than combination therapy.
Raltegravir inhibits the catalytic activity of HIV-1 integrase, and does not significantly inhibit human phosphoryl transferases including DNA polymerases α, β, and γ, and may have less adverse effects. In chronic HBV infection, HBV-DNA does integrate into human DNA which results in difficulty eradicating HBV from the patient's body.
In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Yunnan Provice
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Kunming、Yunnan Provice、中国、650301
- Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
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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:
- Ability and willingness to provide written informed consent
- HIV-1 infection, documented in patient medical record. Acceptable forms of documentation include positive HIV antibody or detectable HIV RNA
- HIV-1 antiretroviral therapy naïve
- Chronic HBV infection, defined as HBsAg positive >6 months. Both HBeAg positive and negative subjects will be eligible
- Detectable HBV DNA ( > 300 copies/ml)
- Serum alpha-fetoprotein (AFP) of ≤ 50 ng/ml within 4 weeks of study entry, or if elevated > 50 ng/ml, an imaging study demonstrating no evidence of hepatic tumor within 4 weeks of enrollment
Exclusion Criteria:
- Allergy or sensitivity to study drug
- Pregnancy, breastfeeding or unwillingness/inability to adhere to contraceptive methods for the duration of the study (Female study volunteers must not participate in a conception process (e.g., active attempt to become pregnant). If participating in sexual activity that could lead to pregnancy, the female study volunteer must use the following forms of contraception while receiving study-specific medication(s) and for 30 days after stopping the medication. One of the following methods MUST be used appropriately: (1)Condoms* (male or female) with or without a spermicidal agent; (2)Diaphragm or cervical cap with spermicide; (3)IUD; (4)Hormonal-based method.Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission.
- Prisoners or subjects who are incarcerated
- Receipt of the following drugs with anti-HBV activity within 90 days prior to study entry or anticipated receipt during the course of the study including: ADV, telbivudine, alpha interferon, and other investigational agents with anti-HBV activity
- Active opportunistic infection
- Other causes of chronic liver disease identified (autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
- Concurrent malignancy requiring cytotoxic chemotherapy
- Decompensated or Child's C cirrhosis
- Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
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：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：A:Raltegravir + tenofovir+lamivudine
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raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
他の名前：
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アクティブコンパレータ：B:Efavirenz+tenofovir+lamivudine
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efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Frequency and severity of adverse events
時間枠：In 48 weeks (from baseline to study completion at 48 weeks)
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The investigators will collect the adverse events at every follow-up, and record them in CRFs.
All AEs during the study will be analyzed according to the type, frequency and severity.
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In 48 weeks (from baseline to study completion at 48 weeks)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change of plasma HIV-1 RNA levels
時間枠：week 0,24 and 48
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week 0,24 and 48
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Change of Peripheral blood CD4 cell counts
時間枠：week 0,4,8,12,24,36 and 48
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week 0,4,8,12,24,36 and 48
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Change of plasma HBV-DNA levels
時間枠：week 0,12,24,36,and 48
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week 0,12,24,36,and 48
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Change of serum total bilirubin levels（TBI）
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe)
時間枠：week 0,12,24,36,and week 48
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week 0,12,24,36,and week 48
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Emergence of drug resistance mutations, if appropriate
時間枠：week 0, 24 and 48
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week 0, 24 and 48
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Paired liver biopsy comparison according to inflammatory activity and fibrosis score
時間枠：week 0 and 48
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week 0 and 48
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Change of serum alanine aminotransferase levels (ALT)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of serum aspartate aminotransferase levels (AST)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of blood urine nitrogen levels (BUN)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of serum creatinine levels (SCr)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of blood haemoglobin levels (HB)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of white blood cell counts (WBC)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of blood platelet counts (PLT)
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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Change of urine protein levels
時間枠：week 0,2,4,8,12,24,36 and 48
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week 0,2,4,8,12,24,36 and 48
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Cheng Xi Wang, M.D.、Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
研究記録日
主要日程の研究
研究開始
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 (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
その他の研究ID番号
- MSD-38154
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