Completed

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

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What is being tested

Nevirapine

+ Zidovudine

+ Zalcitabine

Drug
Who is being recruted

Blood-Borne Infections+13

+ 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 4, 2021
Sourced from a government-validated database.Claim as a partner

The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity. Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted. Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 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

1292 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 DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Required: PCP prophylaxis. Allowed: Erythropoietin maintenance. G-CSF and GM-CSF. Prophylaxis for Mycobacterium avium intracellulare. Antifungal prophylaxis or treatment with specific drugs. Maintenance therapy for opportunistic infection. Over-the-counter medications or alternative therapies such as vitamins and herbs. Antibiotics as clinically indicated. Steroids for < 21 days for acute problems. Antipyretics, analgesics, allergy medication, antidepressants, sleep medications, oral contraceptives, or other appropriate medications. Concurrent Treatment: Allowed: Radiation therapy for cutaneous Kaposi's sarcoma. Acupuncture. Patients must have: Documented HIV infection. CD4 count <= 50 cells/mm3. Either no prior nucleoside therapy OR a history of prior nucleoside therapy in the absence of high-grade intolerance. Life expectancy of at least 6 months. Consent of parent or guardian if < 18 years of age. Normal chest x-ray at baseline or within 6 months prior to study entry in the absence of new pulmonary or cardiac symptoms (per 12/28/94 amendment). NOTE: Patients who withdrew from protocol ACTG 193 therapy prior to activation of ACTG 193A are not eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Abnormal baseline chest x-ray. New pulmonary or cardiac symptoms. Psychological or emotional problems sufficient to prevent compliance with study medication. Concurrent Medication: Excluded: Systemic chemotherapy for malignancy. Acute or induction therapy for opportunistic infection. Antiretroviral drugs other than study drugs. Biological response modifiers. Erythromycin, phenytoin, phenobarbital, warfarin, or coumadin. Patients with the following prior conditions are excluded: History of recurrent grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Evidence of active pulmonary disease within 6 months prior to study entry. History of grade 3 or worse peripheral neuropathy. History of acute or chronic pancreatitis. Prior Medication: Excluded: Prior nevirapine. Excluded within 7 days prior to study entry: Acute therapy for opportunistic infection (maintenance therapy is permitted). Acute systemic therapy for a nonopportunistic infection or other medical condition. Antiretroviral drugs other than AZT, ddI, or ddC. Biological response modifiers. d4T therapy. Nucleosides other than those used in the study. Antibiotics containing clavulanate potassium. Prior Treatment: Excluded: More than 4 units of blood in a 30-day period. Active alcohol or drug 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 96 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Children's Hosp of Los Angeles

Los Angeles, United States

Univ of Southern California / LA County USC Med Ctr

Los Angeles, United States

Huntington Memorial Hosp / Children's Hosp of Los Angeles

Pasadena, United States
Completed96 Study Centers