Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients
Safety and Efficacy of Lopinavir/Ritonavir in Combination With Raltegravir in HIV-infected Patients
調査の概要
詳細な説明
This is an open-labeled, non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria. This study will assess the impact of lopinavir/ritonavir in combination with raltegravir on HIV-1
Patients will be evaluated frequently over the 52 weeks of the protocol. Patients will be seen at screening, baseline, week 4, 12, 24, 36, 48, and 52, to include physical examination, assessment for the development of AIDS-defining conditions, hematology, chemistry, lipid profile, CD4, CD8 cell counts, plasma HIV-1 RNA ultrasensitive, and assessment of adverse events. If HIV-1 RNA becomes detectable, this will be repeated for confirmation with 2 weeks. HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of > 1,000 copies/mL.
An interim analysis will be performed when all patients have reached the week 24 visit.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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New Jersey
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Newark、New Jersey、アメリカ、07102
- Saint Michael's Medical 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:
- HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot, positive HIV-1 blood culture, positive HIV serum antigen, or plasma viremia at any time prior to study entry. If no record exists, testing must occur at screening.
- Males and non-pregnant females > 18 years of age. (Children are being excluded as they are immunologically different than adults)
- HIV-1 RNA > 1000 copies/ml for both patient naive and experienced to antiretroviral therapy in order for phenotypic susceptibility to be performed. There in no inclusion criteria for CD4 count.
- Treatment experienced patients , defined as having taken medications from two of the following three classes of antiretrovirals: NRTI, NNRTI, or PI must have phenotypic susceptability to lopinavir/ritonavir as resulted by Phenosense GT
- Laboratory tests ( Cbc w/diff, comprehensive metabolic panel) within pre-specified limits
- Able to sign the informed consent, and is willing to comply with the requirements of this clinical trial.
- Available for at least 52 weeks of follow up
- If female and of child bearing potential must consent to remain abstinent throughout the study period and for 30 days after the last dose of study medications.( this is standard language)
Exclusion Criteria:
- Pregnant or breast-feeding woman (pregnant women are being excluded as drug kinetics are different in pregnancy and the dynamics of immune reconstitution are unknown in this group)
- Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or isolated cutaneous Kaposi's Sarcoma that is not being treated; those with prior cancer diagnosis, such as lymphomas must have been disease-free for at least 5 years
- Absolute neutrophil count < 500, platelet count < 50,000, hemoglobin < 8 gm/dL
- Evidence of end-organ disease, defined as follows: renal (calculated creatinine clearance of less than 50 mL/min); liver (liver-associated enzymes > 3 times the upper limits of normal)
- Grade 3 (ACTG Grading Scale) or higher cholesterol or triglyceride elevations
- Acute, serious infection requiring prescription drug therapy within 30 days prior to study entry
- In the opinion of the investigator, there is evidence of an active ongoing opportunistic infection
- Must not currently be undergoing treatment for an opportunistic infection.
- Use of immune stimulation agents known to impact CD4 cell count in the peripheral circulation, to include IL2, interferon, G-CSF, GM-CSF, etc.
- Use of immune suppressant drugs, with the exception of < 10 mg/day of prednisone .
- Unwillingness to remain abstinent for duration of study
- Experimental vaccines, to include HIV vaccines.
- Patient who is currently enrolled in an experimental protocol, or is receiving an experimental medication.
- Patients on 2 NRTIs with an NNRTI and a PI combination will not be allowed in 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:非ランダム化
- 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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他の:1
open label single arm
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lopinavir/ritonavir 400/100 mg po b.id. in combination with raltegravir 400 mg po b.i.d.
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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The primary objective of this trial is to evaluate the percentage of patients with HIV-1 RNA below 50 copies at week 48 receiving lopinavir/ritonavir in combination with raltegravir
時間枠:week 48
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week 48
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二次結果の測定
結果測定 |
時間枠 |
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To evaluate the effect of lopinavir/ritonavir in combination with raltegravir in maintaining virological suppression
時間枠:weeks 12, 24, 36, and 48
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weeks 12, 24, 36, and 48
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To evaluate the change from baseline in plasma HIV-1 RNA at weeks 12, 24, 36, and 48
時間枠:weeks 12, 24, 36, and 48
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weeks 12, 24, 36, and 48
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協力者と研究者
協力者
捜査官
- 主任研究者:Jihad Slim, MD、Saint Michael's Medical Center
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
その他の研究ID番号
- INV 08/08
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。
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