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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001057
• Other study ID #: ACTG 275
• Secondary ID: 11251
• Status: Completed
• Phase: Phase 2
• Est. completion date: May 1995

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 1995
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Intervention

Drug:
• Zidovudine

• Didanosine

Locations

Country	Name	City	State
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	Univ of Texas Galveston	Galveston	Texas
United States	Hennepin County Med Clinic	Minneapolis	Minnesota
United States	Univ of Minnesota	Minneapolis	Minnesota
United States	Univ of Nebraska Med Ctr	Omaha	Nebraska
United States	Thomas Jefferson Univ Hosp	Philadelphia	Pennsylvania
United States	St Paul Ramsey Med Ctr	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,