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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002176
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011
  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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: May 1997
Study Completion Date: March 2000
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00002176     History of Changes
Other Study ID Numbers: 244C, AI455-062
Study First Received: November 2, 1999
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Pilot Projects
Didanosine
Drug Therapy, Combination
Stavudine
Hydroxyurea
Nelfinavir
Anti-HIV Agents
Viral Load

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

ClinicalTrials.gov processed this record on October 20, 2014