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NCT01976715 · ClinicalTrials.gov registry record

Study of People With HIV Infection Who Have High Viral Loads Despite Combination Antiretroviral Therapy

A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
26
Enrollment target

NCT01976715: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01976715 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01976715 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
26 participants
Enrollment target

Study Summary

Background: \- The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS). Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease the amount of HIV virus in the blood (called viral load) to very low levels. This happens only if the drugs still fight HIV and if taken every day exactly as prescribed. When not taken as directed, or if the ART drugs are not strong enough, the virus can become resistant to them, and the ART will not work to control the virus. Researchers want to know how to control HIV in people who can t lower their viral load with their current ART drugs. Objective: -\<TAB\>To better control HIV in people who can t get a lower viral load even with ART drugs and to learn more about why the HIV is not under control. Eligibility: * People at least 18 years old and with HIV. * People who have been on at least two combinations of ART drugs (including current ART). * People whose last two viral loads were greater than 1,000 copies/mL. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will then have a baseline visit. They will have another physical exam, blood tests, plus answer questions about what they know about HIV and ART, and how they take their ART. * Participants will arrange to stay in the NIH hospital for 7 8 days. * They will take their medications as usual. At the time to take the ART drugs, they will have to ask a nurse to bring them. If they forget, the nurse will bring them. * Participants will meet with a doctor, pharmacist, social worker and nurse to discuss ways to help participants remember to take their drugs. * Participants will have blood drawn about every other day. * Researchers will study the test results. Some participants will be put on different ART drugs. If that happens, participants will have another NIH hospital stay for 7-8 days. * Participants will have 4 follow-up visits over 12 weeks, then eve

Primary Outcome

viral load

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2014-02-11
Est. Completion 2022-12-22

What the finished NCT01976715 record still lists

NCT01976715 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01976715 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01976715 about?

NCT01976715 is a clinical study titled "Study of People With HIV Infection Who Have High Viral Loads Despite Combination Antiretroviral Therapy". Background: \- The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS). Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease the amount of HIV virus in the blood (called viral load) to very low levels. This happens only if the ...

What is the current status of trial NCT01976715?

This trial is currently completed. The enrollment target is 26 participants. The study started on 2014-02-11. Estimated completion is 2022-12-22.

Who is sponsoring clinical trial NCT01976715?

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

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Source: ClinicalTrials.gov NCT01976715, the US trial registry maintained by the National Library of Medicine. NCT01976715 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.