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NCT00002199 · ClinicalTrials.gov registry record · Phase 3

A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.

A Phase 3 study, sponsored by Glaxo Wellcome.

Completed
Registry status
Phase 3
Development phase
550
Enrollment target

NCT00002199: Completed Phase 3 study, sponsored by Glaxo Wellcome.

NCT00002199 is a Phase 3 study that has completed, run by Glaxo Wellcome. The registered enrollment target is 550 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002199, a Phase 3 study, has completed, sponsored by Glaxo Wellcome.

COMPLETED
Registry status
Phase 3
Development phase
550 participants
Enrollment target

Study Summary

To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.

Interventions

  • DRUG Indinavir sulfate
  • DRUG Lamivudine/Zidovudine
  • DRUG Abacavir sulfate

Trial Details

FieldValue
Enrollment Target 550 participants
Phase Phase 3
Glaxo Wellcome

65 total trials

What the finished NCT00002199 record still lists

NCT00002199 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 3 interventions - of which Indinavir sulfate is the first listed.

NCT00002199 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00002199 about?

NCT00002199 is a clinical study titled "A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.". To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defin...

What is the current status of trial NCT00002199?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 550 participants.

What interventions are being tested in trial NCT00002199?

The interventions under investigation include: Indinavir sulfate (DRUG), Lamivudine/Zidovudine (DRUG), Abacavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00002199?

This trial is sponsored by Glaxo Wellcome, which has 65 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00002199's enrollment target sits among peer trials

550 680th of 2000 higher than 1,312 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00002199, the US trial registry maintained by the National Library of Medicine. NCT00002199 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.