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St Paul, Minnesota 55101

  • HIV Infections

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

ACTG 275


NCT ID:

NCT00001057


Secondary ID:

11251


Study Acronym:


Brief Title:

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


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 C


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

105


Enrollment Type:


Overall Contact Information

Official Name:Erice A
Study Chair

Study Dates

Completion Date:May 1995
Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 28, 2012
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Zidovudine
Intervention Type:Drug
Name:Didanosine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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