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

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ClinicalTrials.gov Identifier: NCT00002176

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : April 14, 2011

Sponsor:

Information provided by:

Bristol-Myers Squibb

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections	Drug: Hydroxyurea Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	May 1997
Actual Primary Completion Date :	March 2000
Actual Study Completion Date :	March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Hydroxyurea Stavudine Didanosine Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002176

Locations


United States, California
Univ of California at San Francisco Gen Hosp
San Francisco, California, United States, 94110

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Principal Investigator:	. ., .

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00002176 History of Changes
Other Study ID Numbers:	244C AI455-062
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	April 14, 2011
Last Verified:	April 2011

Keywords provided by Bristol-Myers Squibb:


Pilot Projects Didanosine Drug Therapy, Combination Stavudine	Hydroxyurea Nelfinavir Anti-HIV Agents Viral Load

Additional relevant MeSH terms:


Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Hydroxyurea Nelfinavir	Stavudine Didanosine Antineoplastic Agents Antisickling Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Antimetabolites Reverse Transcriptase Inhibitors

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