Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy
The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low that it cannot be measured (undetectable). The drug that will be added to a treatment is abacavir (ABC).
Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads, for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug (treatment intensification) if the treatment is not working as well as hoped.
調査の概要
詳細な説明
Combination antiretroviral therapy can offer patients potent suppression of HIV replication and improved immunologic functioning. However, despite aggressive antiretroviral regimens currently in use, only about 50 to 60 percent of patients attain plasma viral loads below 50 copies/ml after 24 weeks. Initiating treatment with a 4-drug regimen may increase this percentage, but this may also contribute to patient non-adherence, drug-related toxicities, potential cross-resistance to drugs used in future regimens, and high financial costs. Another strategy is early intensification (adding a single drug to an existing regimen) in patients who are at risk for attaining incomplete viral suppression after 24 weeks of therapy. ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen. The results of this study will offer insight into the potential benefits of early treatment intensification.
Patients entering this study will have initiated potent antiretroviral therapy. Between 60 and 90 days [AS PER AMENDMENT 1/9/01: 60 and 104 days] after beginning their background regimen, patients are randomized to add either ABC (Arm A) or a matching placebo (Arm B) for 12 weeks. Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36. Patients discontinue treatment if virologic failure occurs at any time. Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36, depending on when discontinuation occurred. Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study (through Week 36). Blood samples are collected at Weeks 4, 8, 12, 20, 28, and 36. Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Baseline genotype (presence or absence of PR and RT resistance mutations and number of resistance mutations) is correlated to treatment outcome. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. [AS PER AMENDMENT 5/5/00: Patients and their primary care physicians will be unblinded to the patient's treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 [AS PER AMENDMENT 1/9/01: or if ABC hypersensitivity is suspected].]
研究の種類
入学
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90095
- UCLA CARE Ctr
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Menlo Park、California、アメリカ、94025
- Willow Clinic
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San Jose、California、アメリカ、951282699
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
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Stanford、California、アメリカ、943055107
- San Mateo AIDS Program / Stanford Univ
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Stanford、California、アメリカ、943055107
- Stanford Univ Med Ctr
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Torrance、California、アメリカ、90502
- Harbor UCLA Med Ctr
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Colorado
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Denver、Colorado、アメリカ、80262
- Univ of Colorado Health Sciences Ctr
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Florida
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Miami、Florida、アメリカ、331361013
- Univ of Miami School of Medicine
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory Univ
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern Univ Med School
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Chicago、Illinois、アメリカ、60612
- Cook County Hosp
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hosp
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Baltimore、Maryland、アメリカ、212052196
- State of MD Div of Corrections / Johns Hopkins Univ Hosp
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Missouri
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St Louis、Missouri、アメリカ、63112
- St Louis Regional Hosp / St Louis Regional Med Ctr
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New York
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Buffalo、New York、アメリカ、14215
- SUNY / Erie County Med Ctr at Buffalo
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New York、New York、アメリカ、10003
- Beth Israel Med Ctr
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New York、New York、アメリカ、10016
- Bellevue Hosp / New York Univ Med Ctr
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New York、New York、アメリカ、10032
- Columbia Presbyterian Med Ctr
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New York、New York、アメリカ、10021
- Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
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Rochester、New York、アメリカ、14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill、North Carolina、アメリカ、275997215
- Univ of North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke Univ Med Ctr
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Ohio
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Cincinnati、Ohio、アメリカ、452670405
- Univ of Cincinnati
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Univ of Pennsylvania at Philadelphia
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Philadelphia、Pennsylvania、アメリカ、19104
- Philadelphia Veterans Administration Med Ctr
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South Carolina
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West Columbia、South Carolina、アメリカ、29169
- Julio Arroyo
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- Vanderbilt Univ Med Ctr
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Texas
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Dallas、Texas、アメリカ、75390
- Univ of Texas, Southwestern Med Ctr of Dallas
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Washington
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Seattle、Washington、アメリカ、98104
- Univ of Washington
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San Juan、プエルトリコ、009365067
- Univ of Puerto Rico
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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
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
- Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.)
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have ever taken ABC.
- Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
- Have a fever for 7 days in the 30 days before study entry.
- Have cancer, including Kaposi's sarcoma, that requires chemotherapy.
- Have an active infection that requires treatment in the 21 days before study entry.
- Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry.
- Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study.
- Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination.
- Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.)
- Have received a vaccine in the 21 days before study entry.
- Are pregnant or breast-feeding.
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
- マスキング：ダブル
協力者と研究者
捜査官
- スタディチェア：Pablo Tebas
- スタディチェア：John Bartlett
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了
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。