Completed

An Open Label Trial to Assess Safety and Tolerability of Daclizumab in HIV-Infected Individuals

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections
+11

+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 26, 2004Actual date on which the first participant was enrolled.

The purpose of this protocol is to evaluate the safety and tolerability of an immunosuppressive agent, daclizumab, in HIV-infected adults. HIV-infected individuals with levels of plasma viremia below 30,000 copies/mL will receive daclizumab for one month. Various immunologic and virologic laboratory studies addressing the state of cellular activation and toxicity data will be collected post-enrollment. The primary study risks include factors associated with immunosuppression and fluctuation on HIV viral levels. Subjects will be compensated for participation in this study. Total enrollment for the study will be a maximum of 10 subjects.

Official TitleAn Open Label Trial to Assess Safety and Tolerability of Daclizumab in HIV-Infected Individuals 
NCT00080431
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood-Borne Infections
Urogenital Diseases
Genital Diseases
Communicable Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Lentivirus Infections
Criteria

* INCLUSION CRITERIA: 1. Documentation of HIV-1 infection by licensed ELISA test and confirmed by a Western Blot. 2. Demonstration of control of HIV viremia below the 30,000 copies/mL with a variability of less than 0.5 log of baseline two times within a week and a stable viral load for the previous 3 months. Patient may or may not be on HAART. 3. Patients with CD4 cell count greater than 400 cells/mm(3) at time of screening visit. A variability of 10% between two values is acceptable for values below 400. 4. Ability to sign informed consent and willingness to comply with the study requirements and clinic policies. 5. Age 18-65 years. 6. Willingness to travel to the NIH every 2-4 weeks 7. Need to have a primary doctor who will be taking care of the patients for their HIV infection. 8. Willingness of both women and men to use an effective means of birth control while receiving treatment through this study and 3 months following treatment. Appropriate birth control includes barrier methods, sterilization, and birth control pills. 9. Willing to designate a person for durable power of attorney on the NIH form for medical research and medical care purposes at the NIH Clinical Center. 10. Willing to undergo genetic testing for HLA and willing to have samples stored for future research EXCLUSION CRITERIA: 1. Patients who are pregnant or who are nursing infants will not be eligible. Women of child-bearing potential must have a negative pregnancy test on the day of study entry. 2. Acute or chronic liver disease, history of alcohol abuse or drug abuse that would interfere with participation in the clinical trial. 3. History of any malignant neoplasm except in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years. 4. History of bladder cancer. 5. Previous treatment with daclizumab. 6. Inability to comply with study guidelines. 7. Hemocytopenia: platelet count less than 80,000/mm(3), absolute neutrophil count less than 1500/mm(3), hematocrit less than 30% (in the absence of gastrointestinal bleeding or hemolytic anemia). 8. ALT/AST greater than 5 times the upper limit of normal, PT INR greater than 2 times the upper limit of normal, creatinine greater than 1.5 times the upper limit of normal. 9. Concurrent use of any other immunosuppressive therapy including systemic steroids for a duration of six weeks or more six months prior to enrollment. 10. History of use of the immunomodulatory agent such as IL-2 or interferon within the last 5 years. 11. Known allergy to murine proteins. 12. Medical illness that in the opinion of the investigator might confound results or interfere with the subject's ability to participate in the trial.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United StatesSee the location
CompletedOne Study Center