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A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002230
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  Purpose

To determine the virologic benefits associated with the addition of hydroxyurea (HU) to combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in HIV-infected patients. To assess the safety and tolerance of this regimen, with or without HU.


Condition Intervention Phase
HIV Infections
Drug: Hydroxyurea
Drug: Efavirenz
Drug: Stavudine
Drug: Didanosine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 100
Detailed Description:

HU or placebo is added 30-60 days after the initiation of DMP, ddI, and d4T combination therapy. Patients are stratified according to antiretroviral experience (naive or experienced). Patients are followed for 48 weeks to determine safety, efficacy, and effect of treatment on viral, immunologic,and biochemical parameters.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV infection, as documented by a licensed ELISA that is confirmed either by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or a second antibody test positive by a method other than ELISA.
  • CD4 cell count of at least 100 cells/mm3 within 30 days of study entry.
  • Over 500 HIV-1 RNA copies/ml as measured by the Roche Amplicor or Ultra Sensitive Assay within 30 days of study entry.
  • Treatment-experienced patients must have documented HIV RNA values of less than or equal to 100,000 copies/ml within 30 days of study entry.

Prior Treatment:

Excluded:

Acute therapy for an infection or other medical illness. Acute therapy must have been completed 14 days prior to the time of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Malignancy requiring systemic therapy.

Patients with the following prior conditions are excluded:

  • History of acute or chronic pancreatitis.
  • History of generalized peripheral neuropathy.
  • Inability to tolerate ddI at 200-400 mg/day or d4T at 60-80 mg/day. For purposes of this study, intolerance will be defined as the same recurrent toxicities requiring dose interruptions and dose reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).

Prior Medication:

Excluded:

Antiretroviral therapy. If antiretroviral-experienced, no prior NNRTI's or HU and no more than 12 weeks experience with ddI and/or d4T. Protease inhibitor experience is allowed. Experienced patients must be on a stable antiretroviral therapy 30 days prior to study screening and continue this regimen until study entry.

Risk Behavior:

Excluded:

Current ethanol abuse by personal history or a report from a primary physician.

  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: NCT00002230

Locations
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Robert Murphy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002230     History of Changes
Other Study ID Numbers: 296A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Didanosine
Drug Therapy, Combination
Stavudine
Hydroxyurea
Anti-HIV Agents

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

ClinicalTrials.gov processed this record on November 23, 2014