A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 100/mm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies/Ml and Prior RTI Therapy But No Prior PI Therapy
調査の概要
詳細な説明
This protocol is a stratified, randomized, double-blind, dose-comparative study of the safety and efficacy of adefovir dipivoxil in combination with nelfinavir and saquinavir soft gel capsules (SGC) or adefovir dipivoxil in combination with nelfinavir or saquinavir SGC plus a nucleoside analog (zidovudine, lamivudine, or stavudine).
Patients will be randomized to adefovir dipivoxil with nelfinavir and saquinavir or adefovir dipivoxil with nelfinavir or saquinavir plus a nucleoside analog (zidovudine, lamivudine, or stavudine). Within each treatment arm, patients will be randomized to 1 of 2 doses of adefovir dipivoxil in a blinded manner. Patients randomized to receive a nucleoside analog will then be assigned to receive either zidovudine, lamivudine, or stavudine based upon their previous RTI therapy. A daily dose of L-carnitine will be administered to all patients.
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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Arizona
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Phoenix、Arizona、アメリカ、85016
- Phoenix Body Positive
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California
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Los Angeles、California、アメリカ、900951793
- UCLA CARE Ctr
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Los Angeles、California、アメリカ、90036
- Krauss Med Partners / Dept of Research and Development
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San Francisco、California、アメリカ、94114
- Davies Med Ctr
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Connecticut
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Greenwich、Connecticut、アメリカ、06830
- Blick Med Associates
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District of Columbia
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Washington、District of Columbia、アメリカ、20037
- George Washington Med Ctr
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Univ School of Medicine
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Massachusetts
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Worcester、Massachusetts、アメリカ、01655
- Univ of Massachusetts Med Ctr
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New York
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Manhassett、New York、アメリカ、11030
- North Shore Community Hosp
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74114
- Associates of Med and Mental Health
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Univ of Pennsylvania
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Rhode Island
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Pawtucket、Rhode Island、アメリカ、02860
- Mem Hosp of Rhode Island
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Texas
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Dallas、Texas、アメリカ、75235
- Univ of Texas Southwestern Med Ctr of Dallas
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Ponce、プエルトリコ、00731
- Hosp Regional de Ponce - Area Vieja
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Santruce、プエルトリコ、00908
- San Juan AIDS Program
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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 must have:
- Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture).
- An HIV-1 RNA plasma titer >= 5000 copies/ml within 14-21 days prior to the baseline visit.
- CD4 cell count >= 100 cells/mm3 within 14-21 days prior to the baseline visit.
- A minimum life expectancy of at least 1 year.
- Signed, informed consent from parent or legal guardian for those patients < 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
- Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit.
- Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting that may confer an inability to receive an orally administered medication.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study.
- Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements.
Patients with any of the following prior conditions are excluded:
- A new AIDS-defining event diagnosed within 1 month prior to baseline.
Significant history of peripheral neuropathy.
1. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
Ritonavir, indinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.
1. Prior use of adefovir dipivoxil.
- Prior use of any antiretroviral protease inhibitor.
- Immunizations within 30 days of baseline.
- Antiretroviral vaccine therapy within 60 days of baseline.
- Treatment in the 4 weeks prior to baseline with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- Any other investigational drug within 30 days prior to baseline.
- Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
Required:
Prior therapy for > 4 weeks with any licensed nucleoside analog inhibitor of HIV reverse transcriptase.
Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
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
スポンサー
研究記録日
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
- 232E
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