NCT00068809

Brief Summary

This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral replication in patients who have already had at least 6 months of documented viral suppression with full-time treatment. If this strategy is shown to be safe in this study, a larger study will be undertaken to determine if the strategy can decrease overall drug exposure and help young people adjust more easily to a chronic medication schedule.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jul 2003

Typical duration for phase_4 hiv-infections

Geographic Reach
2 countries

9 active sites

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

July 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

September 10, 2003

Last Update Submit

February 27, 2017

Conditions

HIV Infections

Keywords

Treatment experiencedTreatment interruption

Outcome Measures

Primary Outcomes (1)

  • Assess VL Suppression for Subjects on SCT over a 24 Week and 48 Week Period

    To assess viral load suppression (≤ 400 copies/ml) for subjects on SCT over a 24 week and a 48 week period. The primary endpoint is defined as the time of confirmed VL \> 400 copies/ml at any time after study entry up to and including the 48th week of follow-up.

    48 Weeks

Secondary Outcomes (4)

  • Assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48

    48 Weeks

  • Compare differences in various values from study entry to Weeks 24 and 48

    48 Weeks

  • Assess the adherence level over time

    Week 48

  • Assess genotypic resistance as necessary

    48 Weeks

Study Arms (1)

Short-cycle therapy (SCT)

EXPERIMENTAL

At entry, subjects will switch from continuous HAART to SCT. All subjects will then be followed to assess viral load breakthrough over 48 weeks on SCT.

Procedure: Short Cycle Antiretroviral Therapy

Interventions

Short Cycle Antiretroviral TherapyPROCEDURE
Short-cycle therapy (SCT)

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Twelve to 24 years of age, regardless of the mode of transmission.
  • Subjects must have been on a stable HAART regimen containing at least one PI and two NRTIs and no NNRTI for at least 3 months and be willing to continue the PI-containing regimen throughout the study period.
  • Acceptable viral load defined as at least three plasma HIV-1 RNA levels ≤ 400 copies/ml within 12 months of study entry and no plasma HIV-1 RNA levels \> 400 copies/ml within 6 months of entry date employing any clinically available viral load assay.
  • Pre entry plasma HIV-1 RNA level \<200 copies/ml by ultra-sensitive assay (Roche 1.5) within 30 days of study entry, performed in an assigned PACTG core virology laboratory.
  • CD4+ T cell count \>350 cells/microL within 30 days of study entry.
  • Ability of subject and parent or legal guardian (when appropriate) to give written informed assent/consent and permission respectively.
  • Subjects currently enrolled in ATN 015 Version 2.0 are eligible as follows:
  • Subjects randomized to standard continuous therapy (control arm). These subjects are eligible to be enrolled in ATN 015 Version 3.0 as new subjects if they meet the entry criteria for ATN Version 3.0. If eligible, they will be followed for the full 48 weeks.
  • Subjects randomized to short cycle therapy (experimental arm). These subjects are eligible to rollover to ATN 015 Version 3.0 and continue on SCT if they have not met a study endpoint. These subjects may not have a viral load value that meets a study endpoint (viz. a confirmed viral load of \>400 copies/ml) and will continue on the intensive monitoring until they have completed 24 weeks when they will enter the less intensive 24 week phase of the study.
  • Female subjects must be non-pregnant and willing to remain on effective contraception for the duration of the study. (Examples of acceptable forms of birth control include but are not limited to any form of hormonal contraception along with a barrier method, double barrier method, tubal ligation, or abstinence if it is the choice of the subject.)

You may not qualify if:

  • On a HAART regimen containing an NNRTI or a HAART regimen with Abacavir (including Trizivir®).
  • On any prohibited medication at the time of screening. Subjects with underlying reactive airway disease who are on either inhaled or brief, intermittent systemic steroids can be considered but their status must be reviewed with the protocol chair or vice chair through the standard ATN protocol query process.
  • Active HIV-related opportunistic infection or any malignancy at the time of screening. (Female subjects who have been treated adequately for cervical dysplasia or CIN are eligible for study unless they are on systemic immunosuppressive therapy).
  • Current treatment for known or suspected active serious bacterial infection.
  • Pregnancy.
  • Any laboratory abnormalities Grade 3 or greater as defined in Appendix III at the time of screening.
  • Subjects receiving pharmacological treatment for elevated cholesterol and triglyceride levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Children's Hopsital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of California at San Diego

San Diego, California, 92102, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

Stoger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Mt. Sinai Hospital

New York, New York, 01129, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Puerto Rico

San Juan, 00927, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bret J Rudy, MD

    Children's Hospital of Philadelphia, The University of Pennsylvania School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

July 1, 2003

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

March 1, 2017

Record last verified: 2016-02

Locations

US(8)PR(1)