A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Hydroxyurea
* Drug: Nelfinavir mesylate
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Documented HIV infection. CD4 count > 500 cells/mm3. 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. Exclusion Criteria 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 2. 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. 1. 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.

Ages Eligible for Study
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Minimum Age: 16 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hydroxyurea|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Stavudine|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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Anti-HIV Agents, Pilot Projects, Didanosine, Drug Therapy, Combination, Stavudine, Hydroxyurea, Nelfinavir, Viral Load