CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 635 enrolled
Drug / intervention
ARCHITECT HIV Ag/Ab Combo +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00933933
NCT00933933Phase 3Completed
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Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

Abbott Diagnostics Division·interventional·Posted Jul 7, 2009·Updated Jul 12, 2011

In Brief

A Phase 3 clinical trial evaluating ARCHITECT HIV Ag/Ab Combo for Human Immunodeficiency Viruses. Completed, enrolled 635 participants across 13 sites.

Detailed Summary

To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Viruses
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.0 years ago

Interventions

ARCHITECT HIV Ag/Ab Combodevice

Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.

ARCHITECT HIV Ag/Ab Combodevice

Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.