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NCT00000885 · ClinicalTrials.gov registry record · Phase 2

Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320

A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
440
Enrollment target
20
Study locations

NCT00000885 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 440 participants, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target. The trial reports 20 study locations across 9 states.

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The verdict

NCT00000885, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
440 participants
Enrollment target
20
Study locations

Study Summary

Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. \[AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.\] \[AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.\] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasm

Conditions Studied

HIV Infections

Interventions

  • DRUG Levocarnitine
  • DRUG Efavirenz
  • DRUG Indinavir sulfate
  • DRUG Nelfinavir mesylate
  • DRUG Abacavir sulfate

Study Locations (20)

California

  • Univ of Southern California / LA County USC Med Ctr - Los Angeles
  • Stanford at Kaiser / Kaiser Permanente Med Ctr - San Francisco
  • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium - San Jose
  • San Mateo AIDS Program / Stanford Univ - Stanford
  • Stanford Univ Med Ctr - Stanford
  • Harbor UCLA Med Ctr - Torrance

Illinois

  • Northwestern Univ Med School - Chicago
  • Cook County Hosp - Chicago
  • Rush Presbyterian - Saint Luke's Med Ctr - Chicago
  • Louis A Weiss Memorial Hosp - Chicago

District of Columbia

  • Georgetown Univ Hosp - Washington D.C.
  • Howard Univ - Washington D.C.

Hawaii

  • Queens Med Ctr - Honolulu
  • Univ of Hawaii - Honolulu

Indiana

  • Indiana Univ Hosp - Indianapolis
  • Division of Inf Diseases/ Indiana Univ Hosp - Indianapolis

Alabama

  • Univ of Alabama at Birmingham - Birmingham

Colorado

  • Univ of Colorado Health Sciences Ctr - Denver

Florida

  • Univ of Miami School of Medicine - Miami

Trial Details

FieldValue
Enrollment Target 440 participants
Est. Completion 2003-06
Phase Phase 2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000885

The ClinicalTrials.gov registry entry for NCT00000885 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Levocarnitine is the first listed.

NCT00000885 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Illinois, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00000885 about?

NCT00000885 is a clinical study titled "Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320". Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerabili...

What is the current status of trial NCT00000885?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 440 participants. Estimated completion is 2003-06.

What conditions does trial NCT00000885 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000885?

The interventions under investigation include: Levocarnitine (DRUG), Efavirenz (DRUG), Indinavir sulfate (DRUG), Nelfinavir mesylate (DRUG), Abacavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00000885?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000885 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.