NCT00051818

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Sep 2000

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2003

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

February 9, 2016

Status Verified

December 1, 2005

Enrollment Period

2.7 years

First QC Date

January 16, 2003

Last Update Submit

February 8, 2016

Conditions

HIV Infections

Keywords

chronic HIV infectiontreatment interruptionHIV-specific immune responseimmune responsevirological responsetreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression

Secondary Outcomes (3)

  • 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

Interventions

Treatment interruption/reinitiation scheduleBEHAVIORAL

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Wistar Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • Montaner LJ. Structured treatment interruptions to control HIV-1 and limit drug exposure. Trends Immunol. 2001 Feb;22(2):92-6. doi: 10.1016/s1471-4906(00)01809-3.

    PMID: 11286710BACKGROUND

  • Papasavvas E, Kostman JR, Mounzer K, Grant RM, Gross R, Gallo C, Azzoni L, Foulkes A, Thiel B, Pistilli M, Mackiewicz A, Shull J, Montaner LJ. Randomized, controlled trial of therapy interruption in chronic HIV-1 infection. PLoS Med. 2004 Dec;1(3):e64. doi: 10.1371/journal.pmed.0010064. Epub 2004 Dec 28.

    PMID: 15630469RESULT

  • Papasavvas E, Grant RM, Sun J, Mackiewicz A, Pistilli M, Gallo C, Kostman JR, Mounzer K, Shull J, Montaner LJ. Lack of persistent drug-resistant mutations evaluated within and between treatment interruptions in chronically HIV-1-infected patients. AIDS. 2003 Nov 7;17(16):2337-43. doi: 10.1097/00002030-200311070-00008.

    PMID: 14571185RESULT

  • Papasavvas E, Azzoni L, Ross BN, Fair M, Howell BJ, Hazuda DJ, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Comparable HIV suppression by pegylated-IFN-alpha2a or pegylated-IFN-alpha2b during a 4-week analytical treatment interruption. AIDS. 2021 Oct 1;35(12):2051-2054. doi: 10.1097/QAD.0000000000002961.

    PMID: 34049356DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Treatment Interruption

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Treatment Adherence and ComplianceAttitude to HealthDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Luis J. Montaner

    The Wistar Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, HIV-1 Immunopathogenesis Laboratory

Study Record Dates

First Submitted

January 16, 2003

First Posted

January 24, 2003

Study Start

September 1, 2000

Primary Completion

May 1, 2003

Study Completion

July 1, 2003

Last Updated

February 9, 2016

Record last verified: 2005-12

Locations

US(1)