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NCT00000891 · ClinicalTrials.gov registry record · Phase 2

Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315

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

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT00000891: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000891 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000891, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART. Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART.

Interventions

  • DRUG Lamivudine
  • DRUG Ritonavir
  • DRUG Stavudine
  • DRUG Delavirdine mesylate
  • DRUG Saquinavir

Trial Details

FieldValue
Enrollment Target 34 participants
Est. Completion 2004-05
Phase Phase 2

What the finished NCT00000891 record still lists

NCT00000891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

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

NCT00000891 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000891 about?

NCT00000891 is a clinical study titled "Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315". To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To ...

What is the current status of trial NCT00000891?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. Estimated completion is 2004-05.

What interventions are being tested in trial NCT00000891?

The interventions under investigation include: Lamivudine (DRUG), Ritonavir (DRUG), Stavudine (DRUG), Delavirdine mesylate (DRUG), Saquinavir (DRUG).

Who is sponsoring clinical trial NCT00000891?

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 NCT00000891's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00000891, the US trial registry maintained by the National Library of Medicine. NCT00000891 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.