Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Zidovudine

+ Didanosine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Hennepin County Med Clinic

Minneapolis, United StatesOpen Hennepin County Med Clinic in Google Maps

Univ of Minnesota

Minneapolis, United States

St Paul Ramsey Med Ctr

Saint Paul, United States

Univ of Nebraska Med Ctr

Omaha, United States
Completed7 Study Centers