Immune and Viral Outcomes of HIV-1 Therapy Interruption
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Purpose
The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Treatment interruption/reinitiation schedule |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Immune and Viral Outcomes of HIV-1 Therapy Interruption |
- 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
| Estimated Enrollment: | 42 |
| Study Start Date: | September 2000 |
Our preliminary studies have shown that structured treatment interruption of highly active antiretroviral therapy (HAART) may boost patients’ immune responses to HIV-1. In this study, we will test the hypothesis that repeated structured treatment interruptions will increase HIV-1 immunity and result in better control of viral replication than in controls. We will test this hypothesis by determining time to viral rebound after withdrawal of antiretroviral therapy in a randomized, non-blinded study of a well-characterized subject population from a single center. Patients in this study will be randomized to either treatment interruption or control groups. Patients will be monitored for adherence to therapy and changes in immune status following HAART interruption. CD4 percentage, CD 4 and CD8 mediated anti-HIV-1 responses, cell surface T-cell antigen expression, and thymic function will be assessed.
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00051818 History of Changes |
| Other Study ID Numbers: | 5R01AI48398-01, 5R01AI048398-03 |
| Study First Received: | January 16, 2003 |
| Last Updated: | December 6, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
chronic HIV infection treatment interruption HIV-specific immune response |
immune response virological response treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 13, 2013