A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Study Overview
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Brief Summary
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The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

Detailed Description
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The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load. In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV. Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Official Title
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RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Ritonavir
* Drug: Nelfinavir mesylate
* Drug: Nevirapine
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Zidovudine
* Drug: Zalcitabine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Your child may be eligible for this study if he or she: Is HIV-positive. Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18). Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy. Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy. Is able to receive at least one of the following: RTV, NVP, or NFV. Exclusion Criteria Your child will not be eligible for this study if he or she: Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry. Has a history of pancreatitis or peripheral neuropathy. Has cancer requiring chemotherapy. Is allergic to the study medications. Is taking certain medications. Is pregnant.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritonavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Nevirapine|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Zidovudine|nan|
|Drug: Zalcitabine|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Nevirapine, Stavudine, Ritonavir, Lamivudine, RNA, Viral, Anti-HIV Agents, Nelfinavir