A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	October 1, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
Official Title ^ICMJE	A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
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 these drugs over CD4 cell counts.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Hydroxyurea Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients must have the following symptoms and conditions: Treatment naive. Recent HIV infection. Baseline laboratory values within acceptable ranges. Written, informed consent from parent or legal guardian for patients < 18 years old. Available for follow-up for at least 96 weeks. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: Documentation of other cause for previously mentioned clinical conditions. 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.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002177
Responsible Party
Study ID Numbers ^ICMJE	244D, AI455-063
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP