このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Strategies for Delivering Anti-HIV Therapy in South Africa

2007年9月17日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)

Safeguard the Household: A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country

Providing effective anti-HIV therapy in developing countries is challenging. This study will evaluate new strategies for delivering anti-HIV medications to people in South Africa. These strategies include using specially trained nurses to administer therapy (rather than doctors), treating all HIV infected members of a household at the same time, and having community members observe patients taking their medications.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The benefit of antiretroviral therapy is well established but limited to wealthy nations. A predefined, simple sequence of treatment regimens focused on extending the durability of limited treatment options has the best potential to be implemented in resource poor countries. South Africa has 15% of the world's HIV/AIDS patients and a limited number of physicians to treat them (l per 1,600 and less than 5 infectious diseases specialists). HIV patient care in the primary care setting must therefore be delivered by personnel other than doctors. Further, treatment strategies should include entire households to ensure maximum adherence and minimize sharing of drugs.

This study will have two parts. The first part will compare a first-line antiretroviral therapy regimen administered and monitored by primary health care sisters (nurses) with the same regimen administered by doctors. The second part of the study will determine if community-based directly observed therapy (DOT) is significantly superior to continued clinic-based treatment support for patients who have failed first-line therapy, as measured by cumulative virology failure rate. The project will also evaluate the cost and economic impact of a predetermined schedule of antiretroviral therapy; treatment outcomes in terms of morbidity, opportunistic and endemic infections, and mortality; and factors contributing to treatment failure, including toxicity, resistance, compliance, and treatment interruption.

In Part 1, households will be randomly assigned to receive first-line antiretroviral therapy under the monitoring and care of either an HIV-trained medical doctor supported by adherence counselors or an HIV-trained primary health care sister (nurse with training in diagnosis and treatment prescription). Members of the household who are HIV infected will receive stavudine, lamivudine, and efavirenz (nevirapine or nelfinavir may be used for special populations).

Participants who fail first-line antiretroviral therapy in Part 1 of the study will be entered into Part 2 of the study. Participants in Part 2 will receive zidovudine, didanosine, and lopinavir/ritonavir. Participants will be randomly assigned to have their treatment monitored through either a clinic-based treatment support group or through community-based directly observed treatment (DOT). For the DOT arm, a community member will observe therapy for at least one dose a day, five days a week, at the home or work of the participant.

HIV infected children age 3 months to 16 years who live in a participating household will also be included in the study. These children will receive first-line treatment with clinic visits monitored by either the assigned sister (nurse) or doctor along with their households. In Part 2, children will be provided with a second-line treatment regimen with continued daily monitoring of doses in the household.

The study will last 5 years.

研究の種類

介入

入学

813

段階

  • 適用できない

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

  • 南アフリカ
    • Gauteng
      • Johannesburg、Gauteng、南アフリカ、2013
        • University of the Witwatersrand/Clinical HIV Research Unit
    • South Peninsula
      • Cape Town、South Peninsula、南アフリカ、8005
        • University of Cape Town/Masiphumelele

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

3年歳以上 (子、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 for the first person in the household who enters the study:

  • HIV infected
  • Older than 16 years of age
  • History of a severe CDC Category B or C AIDS-defining illness or a CD4 cell count less than 350 cells/mm3 within 6 months prior to study entry
  • Have not previously taken anti-HIV medications. People who have taken anti-HIV medications for post-exposure prophylaxis or prevention of mother-to-child transmission may be eligible if the previous exposure did not exceed 6 weeks of nucleoside reverse transcriptase inhibitors or protease inhibitors, or two doses of a non-nucleoside reverse transcriptase inhibitor.

Inclusion Criteria for children between 3 and 16 years old in a household that has been entered in the study:

  • HIV infected
  • Live in house with an adult participating in the study
  • History of severe CDC Category B or C AIDS-defining illness, with the exception of a single episode of bacterial sepsis or a single episode of Zoster; or one CD4% less than 20% (less than 25% for children 3 to 18 months) obtained within 6 months prior to study entry
  • Have not previously taken anti-HIV medications. Children who have taken anti-HIV medications for post-exposure prophylaxis or prevention of mother-to-child transmission may be eligible if the previous exposure did not exceed 6 weeks of nucleoside reverse transcriptase inhibitors or protease inhibitors, or two doses of a non-nucleoside reverse transcriptase inhibitor therapy. Children who received 6 weeks of AZT or a single dose of nevirapine will be included in the study.
  • Consent of parent or legal guardian
  • Primary caregiver who is willing and able to administer anti-HIV medications

Exclusion Criteria:

  • Newly diagnosed AIDS-defining (CDC Classification C) opportunistic infection or condition requiring acute therapy at the time of enrollment. A stable patient on therapy for more than 7 days may be enrolled. Patients who tuberculosis treatment within 8 weeks of the baseline visit are not excluded.
  • Use of medications with significant effect on bone marrow, nervous system, pancreas, or liver within 30 days prior to study entry
  • Use of cytotoxic medications within 30 days prior to study entry
  • Active alcohol or substance abuse
  • Severe diarrhea (more than 6 stools/day for 7 consecutive days) within 30 days prior to study entry
  • Acute hepatitis within 30 days prior to study entry
  • Bilateral peripheral neuropathy of Grade 2 or greater at the time of screening
  • Women in the first trimester of pregnancy
  • Women who have failed a lopinavir/ritonavir treatment regimen in Part I and who are either pregnant at entry into Part 2 or are of childbearing potential with a CD4 count of 250 cells/mm3 or more
  • Inability to tolerate oral medication
  • Any clinical condition that, in the opinion of the investigator, would make the person unsuitable for the study or unable to comply with the dosing requirements

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：ランダム化
  • 介入モデル：階乗代入
  • マスキング：なし（オープンラベル）

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
Cumulative treatment failure rate, determined by comparing a primary health care level first line antiretroviral therapy regimen to a doctor monitored treatment regimen
48-week cumulative virology failure rate, determined by comparing community-based directly observed therapy (DOT) by identified and trained community members to continued clinic-based treatment support for subjects who have failed first line therapy

二次結果の測定

結果測定
Overall clinical safety of antiretroviral therapy, as measured by the occurrence of clinical and laboratory Grade 3 and 4 adverse events, between primary health care monitoring arms in adults and children
CD4+ count, viral load, drug toxicity, adherence, participation in MTCT programs, intercurrent medical conditions, age as factors potentially contributing to cumulative treatment failure in participants age 16 and older
cumulative treatment failure rate between groups, defined by clinical staging (CDC and WHO classification) prior to initiation of antiretroviral therapy and monitoring arms in adults and children
cumulative treatment failure rate of second line therapy from time of Phase 1 randomization in adults and children, between the doctor and the primary health care sister-based monitoring arm
comparison of immune reconstitution in adults and children, using change in CD4+ percent from baseline between the two treatment monitoring models over the duration of the study
comparison of HIV resistance mutations in adults and children who have demonstrated virologic failure between the doctor and the primary health care sister-based monitoring arms
comparison of adherence to antiretroviral treatment in Phase 1 in both adults and children as measured by pill count (or weight or volume of drug solution) between the two primary health care monitoring models
comparison of adherence to antiretroviral treatment in adults as measured by pill count between those randomized to community-based DOT and those randomized to continued clinic-based adherence support
comparison of HIV disease progression/death in adults and children between the two primary health care monitoring arms
total and incremental costs of adding the 4 approaches for the provision of antiretrovirals to primary health care services in each study site
potential costs to the government of provincial and national based scale-up for the provision of antiretroviral therapy in the short, long and medium term and resulting net costs/savings of each approach as a national strategy
relative cost effectiveness of the introduction of the four alternative models of HAART provision versus no provision, using life-years gained and quality adjusted life-years gained
household preferences for various aspects of antiretroviral therapy provision program design, including assessing their relationship with adherence
personnel required for a nurse-based monitoring program, including the training process and implementation

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

National Institute of Allergy and Infectious Diseases (NIAID)

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

2005年2月1日

研究の完了 (実際)

2007年1月1日

試験登録日

最初に提出

2004年4月6日

QC基準を満たした最初の提出物

2004年4月6日

最初の投稿 (見積もり)

2004年4月7日

学習記録の更新

投稿された最後の更新 (見積もり)

2007年9月18日

QC基準を満たした最後の更新が送信されました

2007年9月17日

最終確認日

2007年8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

  • 5U19AI053217-02 (米国 NIH グラント/契約)
  • CIPRA-SA Project 1

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。

購読する