Immune and Viral Outcomes of HIV-1 Therapy Interruption
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00051818 |
Recruitment Status :
Completed
First Posted : January 24, 2003
Last Update Posted : February 9, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Treatment interruption/reinitiation schedule | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immune and Viral Outcomes of HIV-1 Therapy Interruption |
Study Start Date : | September 2000 |
Actual Primary Completion Date : | May 2003 |
Actual Study Completion Date : | July 2003 |
- Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression
- Safety of sequential STIs
- changes in immune reconstitution in relation to sequential STIs, including CD4 T-cell changes, recall responses, and T-cell activation, as measured by cell surface antigen changes
- genotypic changes occurring in HIV-1 protease and reverse transcriptase regions after sequential STIs and their relation to clinical failure under the ART regimen at study entry

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Ages Eligible for Study: | 17 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- HIV-1 positive
- HIV RNA < 500 copies/ml on a regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) and either one protease inhibitor (PI) or one nonnucleoside reverse transcriptase inhibitor (NNRTI) for 6 months prior to study entry - HIV RNA < 50 copies/ml at study screening
- CD4 > 400 cells/mm3 with CD4 nadir of > 100 cells/mm3
- Agree to Medication Event Monitoring System monitoring of one component of antiretroviral regimen
- HIV-1 viral load >10,000 copies/ml at any time prior to initiating the current uninterrupted HAART regimen
- Willing to abstain from all immunomodulatory drugs during the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051818
United States, Pennsylvania | |
The Wistar Institute | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Luis J. Montaner | The Wistar Institute |
Other Publications:
Responsible Party: | Luis Montaner, Professor and Director, HIV-1 Immunopathogenesis Laboratory, The Wistar Institute |
ClinicalTrials.gov Identifier: | NCT00051818 |
Other Study ID Numbers: |
5R01AI048398-01 ( U.S. NIH Grant/Contract ) AI048398 |
First Posted: | January 24, 2003 Key Record Dates |
Last Update Posted: | February 9, 2016 |
Last Verified: | December 2005 |
chronic HIV infection treatment interruption HIV-specific immune response |
immune response virological response treatment experienced |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |