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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002177
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011

November 2, 1999
April 13, 2011
May 1997
March 2000   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002177 on ClinicalTrials.gov Archive Site
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A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Hydroxyurea
  • Drug: Nelfinavir mesylate
  • Drug: Stavudine
  • Drug: Didanosine
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2000
March 2000   (final data collection date for primary outcome measure)

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.

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002177
244D, AI455-063
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP