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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 - Article


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Hydroxyurea

Droxia; Hydrea



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

This study is no longer recruiting patients.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

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 these drugs over CD4 cell counts.

Condition Treatment or Intervention
HIV Infections
 Drug: Hydroxyurea
 Drug: Nelfinavir mesylate
 Drug: Stavudine
 Drug: Didanosine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


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

More Information

Study ID Numbers:  244D; AI455-063
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002177
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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