The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001057
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3.

Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Didanosine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 105
Study Completion Date: May 1995
Detailed Description:

Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.

Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antibiotics for bacterial infections as clinically indicated.
  • Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.
  • Antipyretics.
  • Analgesics.
  • Allergy medications.
  • Oral contraceptives.
  • Nonprescription medications such as vitamins or herbal therapies.

Concurrent Treatment:

Allowed:

  • Radiation therapy to local lesion only.
  • Acupuncture.

Patients must have:

  • HIV seropositivity.
  • CD4 count >= 550 cells/mm3.
  • No ARC or AIDS conditions by CDC criteria.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Presence of factors predisposing to pancreatitis such as active alcoholism.
  • Other medical conditions that would interfere with study compliance.

Concurrent Medication:

Excluded:

  • Other antiretrovirals or systemic immunomodulators.
  • Systemic corticosteroids.
  • Systemic cytotoxic chemotherapy.
  • Intravenous pentamidine.

Concurrent Treatment:

Excluded:

  • Radiation therapy except to local lesion.

Patients with the following prior conditions are excluded:

  • History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.
  • History of grade 2 or worse peripheral neuropathy.
  • History of pancreatitis.
  • Bacterial infection requiring antibiotics within 14 days prior to study entry.

Prior Medication:

Excluded:

  • Prior HIV therapy with antiretrovirals or systemic immunomodulators.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

  • Transfusion.

Active substance abuse or alcoholism.

  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: NCT00001057

Locations
United States, Minnesota
Hennepin County Med Clinic
Minneapolis, Minnesota, United States, 55415
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
St Paul Ramsey Med Ctr
St Paul, Minnesota, United States, 55101
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Sponsors and Collaborators
Investigators
Study Chair: Erice A
Study Chair: Balfour H
Study Chair: Carey J
Study Chair: Henry K
Study Chair: Hasse A
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001057     History of Changes
Other Study ID Numbers: ACTG 275, 11251
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Therapy, Combination
Zidovudine

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
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014