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

NCT01976715 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2025-09-23

No results posted yet for this 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 every 3 months for 2 years or more.

Conditions

  • Acquired Immune Deficiency Syndrome Virus
  • Acquired Immunodeficiency Syndrome Virus
  • AIDS Virus
  • Human Immunodeficiency Virus
  • Human Immunodeficiency Viruses

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Alice K Pau, Pharm.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-11
Primary Completion
2022-12-22
Completion
2022-12-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976715 on ClinicalTrials.gov