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| Sponsored by: |
Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002176 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Hydroxyurea Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
| Official Title: | A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.
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.
Active alcohol or substance abuse.
Contacts and Locations| United States, California | |
| Univ of California at San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Principal Investigator: | . ., . | . |
More Information
| Study ID Numbers: | 244C, AI455-062 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002176 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pilot Projects Didanosine Drug Therapy, Combination Stavudine |
Hydroxyurea Nelfinavir Anti-HIV Agents Viral Load |
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Antimetabolites HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Stavudine Anti-HIV Agents Hydroxyurea Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes |
Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Nelfinavir Retroviridae Infections |
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Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hydroxyurea Hematologic Agents Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir |
Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Antisickling Agents Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Didanosine |