Completed

A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA

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What is being tested

Data Collection

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: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration. Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 years. AS PER AMENDMENT 5/9/96: All AZT monotherapy options have been eliminated. Patients will be randomized to either Arm II or Arm III, regardless of their codon 215 status. All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III. All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment.

Official TitleA Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA
NCT00001045
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
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

300 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, ViralHIV InfectionsLentivirus Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: * Chemoprophylaxis for Pneumocystis carinii pneumonia. * Antibiotics, antifungals, and antiviral medications, as clinically indicated. * Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider. Concurrent Treatment: Allowed: * Limited localized radiation therapy to the skin. Prior Medication: Required: * AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry. Patients must have: * Asymptomatic HIV infection. * CD4 count 300-600 cells/mm3. * No plasma/serum PCR for codon 215 mutation at screening. * Prior AZT monotherapy. NOTE: * All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged. AS PER AMENDMENT 04/03/95: * DOD female patients must have a negative pregnancy test within 48 hours prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Symptomatic grade 2 or worse peripheral neuropathy. * Unable to swallow capsules and tablets. * Other medical condition that contraindicates study participation. Concurrent Medication: Excluded: * Systemic cytotoxic chemotherapy. * Biologic response modifiers (such as interferon, ampligen, or PEG-IL2). * Anti-HIV agents other than study drugs. * Other investigational agents. * Foscarnet unless clinically indicated for unresponsive herpes virus infection. * Chronic antacid or H-2 blocker use. * Rifampin or rifamycin class agents. * Antibiotics containing clavulanic acid. Concurrent Treatment: Excluded: * Radiation therapy other than limited localized therapy to skin. Patients with the following prior condition are excluded: * History of pancreatitis. Prior Medication: Excluded: * Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT. * Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening. Prior Treatment: Excluded: * Blood transfusion within the preceding 2 weeks. Illicit drug or alcohol abuse.

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 59 locations

Suspended

UCLA CARE Ctr

Los Angeles, United StatesOpen UCLA CARE Ctr in Google Maps
Suspended

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, United States
Suspended

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, United States
Suspended

San Mateo AIDS Program / Stanford Univ

Stanford, United States
Completed59 Study Centers