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NCT00000841 · ClinicalTrials.gov registry record · Phase 3

A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
1,750
Enrollment target

NCT00000841: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000841 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,750 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000841, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
1,750 participants
Enrollment target

Study Summary

To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.

Interventions

  • DRUG Zidovudine
  • DRUG Lamivudine
  • DRUG Indinavir sulfate
  • DRUG Stavudine

Trial Details

FieldValue
Enrollment Target 1,750 participants
Est. Completion 1997-06
Phase Phase 3

What the finished NCT00000841 record still lists

NCT00000841 is an interventional study that assigns participants to a tested intervention. Its 1,750 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (127% higher).

The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.

NCT00000841 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000841 about?

NCT00000841 is a clinical study titled "A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months". To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies ...

What is the current status of trial NCT00000841?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,750 participants. Estimated completion is 1997-06.

What interventions are being tested in trial NCT00000841?

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

Who is sponsoring clinical trial NCT00000841?

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

How this trial's enrollment target compares

Where NCT00000841's enrollment target sits among peer trials

1,750 129th of 2000 higher than 1,872 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 NCT00000841, the US trial registry maintained by the National Library of Medicine. NCT00000841 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.