NCT00002176已完成不适用
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 1997年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of this therapy over CD4 cell counts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Documented HIV infection.
- •CD4 count > 500 cells/mm
- •No HIV-associated symptoms.
- •Written, informed consent from parent or legal guardian for patients < 18 years old.
- •Availability for follow-up for at least 96 weeks.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions and symptoms are excluded:
- •Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
- •Intractable diarrhea.
- •Signs and symptoms of bilateral peripheral neuropathy >= Grade
- •Inability to tolerate oral medication.
- •Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.
- •Patients with the following prior conditions are excluded:
- •History of acute or chronic pancreatitis.
- •Use of potent neurotoxic drugs is not permitted.
- •No other anti-HIV therapy allowed.
- •Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).
- •1. Any prior antiretroviral therapy.
- •Prior vaccination with a candidate HIV therapeutic vaccine.
- •Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
- •Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.
- •Active alcohol or substance abuse.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV InfectionHIV InfectionsNCT00002177Bristol-Myers Squibb
已完成
4 期
When to Start Anti-HIV Drugs in Patients With Opportunistic InfectionsAIDS-Related Opportunistic InfectionsHIV InfectionsNCT00055120National Institute of Allergy and Infectious Diseases (NIAID)283
已完成
4 期
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM StudyHIV InfectionsNCT03067285Fundacion SEIMC-GESIDA39
进行中（未招募）
4 期
Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-ResistanceHIV-1-infectionNCT05506605Fundacion Clinic per a la Recerca Biomédica12
已完成
4 期
The Dolutegravir Antiretroviral Mono-Therapy for HIV TrialHuman Immunodeficiency VirusNCT02401828Erasmus Medical Center134