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

NCT00001057 | Completed Phase 2

• 2 other identifiers: ACTG 27511251
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Zidovudine

Interventions

Zidovudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

Hennepin County Med Clinic

Minneapolis, Minnesota, 55415, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, 55101, United States

Location

Univ of Nebraska Med Ctr

Omaha, Nebraska, 681985130, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, 191075098, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Zidovudine; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Erice A

  STUDY CHAIR

• Balfour H

  STUDY CHAIR

• Carey J

  STUDY CHAIR

• Henry K

  STUDY CHAIR

• Hasse A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 1995
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (7)