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Kaletra and Viread in Antiretroviral Naïve Patients

2020年12月2日 更新者：Johnny Stephens、Oklahoma State University Center for Health Sciences

A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.

Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.

Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.

研究の種類

介入

入学 (実際)

6

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74127
        • OSU Internal Medicine Specialty Clinic

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Male or female patients >18 years of age with documented HIV-1 infection
  2. Naïve to antiretroviral therapy
  3. Able and willing to provide written informed consent
  4. No CD4 restriction
  5. HIV-1 RNA levels >5000 c/mL

  6. Female patients must meet these additional criteria

    1. Non-childbearing potential
    2. Negative serum pregnancy test at screen
    3. Willingness to abstain from sexual intercourse or use double barrier contraception

Exclusion Criteria:

  1. Presence of any of the following:

    1. Aminotransferases >3xULN
    2. Hemoglobin concentration <8.0g/dl
    3. Absolute neutrophil count <800 cells/cubic mm
    4. Platelet count <50,000 cells/cubic mm
    5. Acute illness, or an acute illness ≤7 days
    6. Presence of Opportunistic Infection, or an OI within 30 days of screening
    7. Acute or chronic active Hepatitis B
    8. Hepatitis C
    9. Creatinine Clearance <50 mL/min
  2. Pregnant or breast-feeding women
  3. Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
  4. Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
  5. Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
  6. Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
実験的：Once daily
Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours.
薬：Once daily
Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
他の名前：
  • ヴィレド
  • カレトラ

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
To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients.
時間枠：4, 8, 12, 16, 24, 32, 40, and 48 weeks
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to <50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
4, 8, 12, 16, 24, 32, 40, and 48 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Patients With <400copies/ml
時間枠：4,8, and 12 weeks
Proportion of patients with <400copies/ml will be done by determining plasma HIV-1 RNA levels
4,8, and 12 weeks
Review Virologic Response to Assess Rate of Viral Decline.
時間枠：weeks 4, 8, 12, 16, and 24
Review virologic response to assess rate of viral decline through CD4 count at baseline and throughout the study.
weeks 4, 8, 12, 16, and 24
Proportion of Patients With <50 Copies/ml HIV-1 RNA
時間枠：at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Proportion of patients with <50 copies/ml HIV-1 RNA through evaluation of patients Plasma HIV-1 RNA levels
at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Change From Baseline CD4 Counts
時間枠：at weeks 4, 8, 12, 16, 24, 32, 40, and 48
CD4 count done at baseline and throughout the study.
at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Time to Virologic Failure.
時間枠：Week 48
Virologic failure is defined by any of the following: 1) <1 log10 decline in HIV RNA by week 8 of therapy; 2) failure to achieve <50 c/mL by week 24; 3) HIV RNA> 500 c/ML on two consecutive occasions (less than 30 days apart), with no evidence of suppression after adherence counseling. When HIV RNA levels are obtained >500 copies/mL it will be repeated within 2 weeks. If after adherence counseling, HIV RNA demonstrates > 1 log 10 decline but remains >500, the patient will receive a final adherence counseling session and have his/her HIV RNA measure repeated at day 30: if a third consecutive HIV RNA remains 500 c/mL the patient will be removed from study, if <500c/mL the patient will remain on study
Week 48
Tolerability and Adverse Events.
時間枠：48 weeks
Adverse events and safety parameters are monitored for ll subjects for the duration of the study. Toxicities and adverse events will be graded using the modified ACTG toxicity ratings scale. Study drugs may be interrupted for safety reasons and/or based on grade of toxicity/adverse event.
48 weeks
Change From Baseline Fasting Total Cholesterol and Fasting Triglyceride Levels.
時間枠：48 weeks
Change from baseline fasting total cholesterol and fasting triglyceride levels will be measured by fasting lipid panels taken at baseline and at various timepoints.
48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by the Use of Medication Electronic Monitoring Systems (MEMS) Caps.
時間枠：48 weeks
The medication event monitoring system (MEMS) is a cap that fits on standard medicine bottles and records the time and date each time the bottle is opened and closed.
48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by Use of Pharmacy Refill Records.
時間枠：48 weeks
Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records is assessed by an examination of pharmacy refill data for patients.
48 weeks
Assess Genotypic Changes in Patients With Virologic Failure.
時間枠：48 weeks
At time of virologic failure genotypes will be performed on baseline and failure isolates; phenotypic testing will be performed on failure isolates to examine LPV susceptibility.
48 weeks
Assess Lopinavir Trough Levels in Patients Failing to Obtain Virologic Suppression.
時間枠：48 weeks
Assess lopinavir trough levels in patients failing to obtain virologic suppression by measuring lopinavir trough level
48 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Oklahoma State University Center for Health Sciences

協力者

Abbott

捜査官

  • 主任研究者：Damon Baker, D.O.、Oklahoma State University Center for Health Sciences

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年5月1日

一次修了 (実際)

2011年5月1日

研究の完了 (実際)

2011年5月1日

試験登録日

最初に提出

2008年5月15日

QC基準を満たした最初の提出物

2008年5月16日

最初の投稿 (見積もり)

2008年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2020年12月4日

QC基準を満たした最後の更新が送信されました

2020年12月2日

最終確認日

2020年12月1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

  • Baker - 001

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Once dailyの臨床試験

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