Completed

Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 12 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 27, 2026
Sourced from a government-validated database.Claim as a partner

Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is often limited by prior exposure, toxicity, or pharmacologic interaction with the protease inhibitors. This study addresses the question of whether to continue 3TC or substitute the nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of plasma HIV-1 RNA. Although the activity of DLV as monotherapy or in combination with nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of resistance, it is possible that DLV will contribute significantly to the activity of 3-drug regimens that include a new RT inhibitor plus a protease inhibitor. Patients with greater than 500 HIV-1 RNA copies/ml are randomized to 3 treatment arms as follows: Arm I: d4T + ZDV placebo + DLV + IDV Arm II: ZDV + d4T placebo + 3TC + IDV Arm III: ZDV + d4T placebo + DLV + IDV Treatment on all arms is given for 24 weeks. \[AS PER AMENDMENT 12/19/97: The study is no longer partially blinded, and placebo agents are no longer given; treatment duration is now 48 weeks.\] \[AS PER AMENDMENT 8/24/98: study duration is now 96 weeks.\] Rollover patients from ACTG 306 with greater than 500 HIV-1 RNA copies/ml previously assigned to ZDV/3TC are nonrandomly assigned to Arm I; those previously assigned to ddI/3TC or d4T/3TC are randomized to Arm II or III. Non-rollover patients are randomized to Arm II or III. Rollover patients from ACTG 306 with 500 HIV-1copies/ml or less continue on their previously assigned regimen \[AS PER AMENDMENT 12/19/98: current regimen must be ZDV/3TC, ddI/3TC, or d4T/3TC.\] for the study duration or until an increase occurs. If this increase occurs, patients previously assigned to ZDV/3TC are nonrandomly assigned to Arm I for the remaining study weeks, while those previously assigned to either ddI/3TC or d4T/3TC are randomized to Arm II or III for the remaining study weeks. Patients who received ddI/d4T or ddI/3TC in ACTG 306 are stratified by whether patients received monotherapy or combination therapy during the first 24 weeks \[AS PER AMENDMENT 12/19/97: 48 weeks\]; \[ AS PER AMENDMENT 8/24/98: 96 weeks.\] of ACTG 306.

Official TitleVirologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
NCT00000882
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 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 12 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: Required: * Patients completing ACTG 306 who remain on blinded therapy through the extension period or * Patients on stable (6 months or greater) ddI/3TC or d4T/3TC combination therapy who have plasma HIV-1 levels higher than 500 copies/ml by the Amplicor HIV-1 Monitor Assay. Allowed following contact with Protocol Pharmacologist: * Diltiazem, nifedipine, phenytoin, and warfarin. Patients must have: * Absolute CD4 count of 200 cells/mm3 or greater. * HIV-1 RNA levels greater than 500 copies/ml by the Amplicor HIV-1 Monitor assay. NOTE: * This is a requirement for those receiving study medication. \[AS PER AMENDMENT 12/19/97: * HIV-1 infection must be documented by any licensed ELISA test kit and confirmed by either Western blot, HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test by a method other than ELISA at any time prior to entry.\] * Signed, informed consent from a parent or legal guardian for patients under 18 years of age. * Life expectancy of at least 24 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Unexplained temperature of 38.5 C or higher for 7 consecutive days, or chronic diarrhea defined as more than 3 liquid stools per day persisting for 15 days, within 30 days prior to study entry. * Proven or suspected acute hepatitis within 30 days prior to study entry. * Malignancy that requires systemic chemotherapy. NOTE:Patients with minimal Kaposi's sarcoma (KS) fewer than 5 cutaneous lesions and no visceral disease or tumor-associated edema) are allowed to enroll provided that they do not require systemic therapy. Concurrent Medication: Excluded: * Concurrent ZDV (for patients other than those rolling over from ACTG 306). * Any experimental antiretroviral agents or other experimental therapies. * Acute therapy for an infection or other medical illnesses within 14 days prior to study entry. * Recombinant erythropoietin (rEPO), G-CSF, or GM-CSF within 30 days prior to study entry. * Interferons, interleukins, or HIV vaccines within 30 days prior to study entry. * Rifampin, rifabutin, cisapride, triazolam, midazolam, terfenadine, astemizole, or loratadine, within 14 days prior to study entry. Patients with the following prior conditions are excluded: * History of acute or chronic pancreatitis. * History of Grade 2 or higher bilateral peripheral neuropathy. \[AS PER AMENDMENT 12/19/97: Patients with Grade 2 or 3 peripheral neuropathy due to current use of ddI/3TC or d4T/3TC and who have a screening viral load above 500 copies/ml are eligible as they will be randomized to a regimen that does not contain an agent associated with peripheral neuropathy toxicity.\] Prior Medication: Excluded: * Prior NNRTI or protease inhibitor therapy. * Prior ZDV (for patients other than those rolling over from ACTG 306). * Previous induction or maintenance therapy with foscarnet.

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 31 locations

Suspended

Univ of Alabama at Birmingham

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

Univ of California / San Diego Treatment Ctr

San Diego, United States
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
Completed31 Study Centers