Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study
調査の概要
詳細な説明
The drug regimen for treatment of HIV at the free ART centers in India includes stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on this regimen experience drug toxicity within the first six months of treatment.
The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART in the Indian governmental program, because it is more expensive than the other drug regimens, in spite of better clinical outcomes in resource limited settings. The cost of treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred first line treatment, but we believe that although the direct cost to the government is less, patients on zidovudine/stavudine regimen have to spend more money for additional hospital visits and admissions, laboratory investigations and other medications due to ART induced toxicity.
There are no published data including economic, clinical and quality of life outcomes to compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative effectiveness study will seek to identify the best treatment for HIV patients based on the incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.
The clinical outcomes include viral suppression, change in the CD4 and proportion of patients with toxicity and opportunistic infections. Direct costs for the treatment will be calculated. The QOL scores will be estimated and compared between the regimens using questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.
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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Tamilnadu
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Vellore、Tamilnadu、インド、632004
- Christian Medical College
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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:
- All treatment naïve patients above 18 years confirmed with the diagnosis of HIV
- Eligible for initiation of cART based on the National Aids Control Organization of India
- Consenting for participation and follow-up for one year.
Exclusion Criteria:
- All patients requiring hospitalization at the time of initiation of treatment
- Patients with opportunistic infections including tuberculosis
- Patients with co-morbidities like diabetes or neurological impairments
- Pregnant and breast feeding women and children less than 18 years will be excluded
- All patients living outside the catchment area of CMC and not willing for regular follow-up will be excluded
- Patients with a creatinine clearance less than 50 mL/min will be excluded.
- Patients receiving other co-medications with possible interaction with tenofovir, like antifungal (voriconazole), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, and methylergonovine), benzodiazepines (midazolam, triazolam), calcium channel blocker (bepridil), GI motility agent (cisapride), neuroleptic (pimozide) and St.John's wort will be excluded.
- Patients with hemoglobin less than 8 gm/dl
- Patients started on tenofovir regimen by the treating physician at the time of enrollment will be excluded
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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アクティブコンパレータ：Zidovudine
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
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zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
他の名前：
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アクティブコンパレータ：Tenofovir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
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tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
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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Viral suppression
時間枠：End of follow-up : end of 12th Month
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End of follow-up : end of 12th Month
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Change in CD4 levels
時間枠：End of Months 6 and 12
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End of Months 6 and 12
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Drug related toxicity
時間枠：Months : 1,2,3,4,5,6,7,8,9,10,11,12
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Months : 1,2,3,4,5,6,7,8,9,10,11,12
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opportunistic infections
時間枠：Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Direct costs
時間枠：Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Months: 1,2,3,4,5,6,7,8,9,10,11,12
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Quality of life
時間枠：Month 1 and end of months 4,8 and 12
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Month 1 and end of months 4,8 and 12
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Christine C Wanke, MD、Tufts University
- 主任研究者：Sowmyanarayanan V Thuppal, MD、Tufts University
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
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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