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The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: July 31, 2008   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001057
  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 II

Study Type: Interventional
Study Design: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001057

Locations
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
St Paul Ramsey Med Ctr
St Paul, Minnesota, United States, 55101
Hennepin County Med Clinic
Minneapolis, Minnesota, United States, 55415
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

Study ID Numbers: ACTG 275
Study First Received: November 2, 1999
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00001057     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Didanosine
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on July 02, 2009