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NCT00085943 · ClinicalTrials.gov registry record · Phase 3

KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
866
Enrollment target

NCT00085943: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT00085943 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 866 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00085943, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
866 participants
Enrollment target

Study Summary

This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

Interventions

  • DRUG Ritonavir
  • DRUG LEXIVA (GW433908)
  • DRUG KALETRA
  • DRUG EPIVIR
  • DRUG Ziagen

Trial Details

FieldValue
Enrollment Target 866 participants
Start Date 2004-05
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT00085943 record still lists

NCT00085943 is an interventional study that assigns participants to a tested intervention. The registered 866 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher).

The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.

NCT00085943 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00085943 about?

NCT00085943 is a clinical study titled "KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks". This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 ...

What is the current status of trial NCT00085943?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 866 participants. The study started on 2004-05.

What interventions are being tested in trial NCT00085943?

The interventions under investigation include: Ritonavir (DRUG), LEXIVA (GW433908) (DRUG), KALETRA (DRUG), EPIVIR (DRUG), Ziagen (DRUG).

Who is sponsoring clinical trial NCT00085943?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00085943's enrollment target sits among peer trials

866 376th of 2000 higher than 1,624 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 NCT00085943, the US trial registry maintained by the National Library of Medicine. NCT00085943 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.