NCT00029341

Brief Summary

The purpose of this study is to find out if anti-HIV drugs can be stopped without the virus becoming resistant to the drugs. The study will also examine how fast anti-HIV drugs leave the body. Not all HIV-infected patients may require continuous and indefinite anti-HIV therapy. There is evidence that stopping anti-HIV therapy will not make the virus resistant to efavirenz (EFV), an anti-HIV drug that remains in the body longer than most treatment drugs. In another study, patients were treated with EFV, zidovudine (ZDV), and lamivudine (3TC). The patients' virus was controlled despite the fact that some patients missed medication dosages. Many patients stop anti-HIV therapy because of negative effects. This study will examine the body's ability to fight and control virus in patients who stop therapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

7 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

First Submitted

Initial submission to the registry

January 10, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2002

Completed
Last Updated

July 30, 2008

Status Verified

January 1, 2005

First QC Date

January 10, 2002

Last Update Submit

July 29, 2008

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationDrug Administration ScheduleDrug Resistance, MicrobialGenotypeReverse Transcriptase InhibitorsAnti-HIV AgentsViral LoadPharmacokineticsEfavirenzTreatment Interruption

Interventions

Treatment InterruptionBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are at least 18 years old.
  • Are on EFV and at least 2 other anti-HIV drugs.
  • Are HIV-infected.
  • Have a CD4 cell count greater than 350 cells/mm3 within 21 days of study entry.
  • Have a viral load less than 50 copies/ml within 21 days of study entry.
  • Have an estimated creatinine clearance greater than 30 ml/minute within 21 days of study entry.
  • Have a negative pregnancy test if female. All patients able to have children must agree not to become pregnant or to impregnate or agree to use 2 reliable methods of contraception, including a barrier method.
  • Are planning to stop anti-HIV drugs as part of another study, not solely to participate in this study.
  • (This study has been changed. In an earlier version, EFV plus lamivudine plus zidovudine or stavudine was required.)

You may not qualify if:

  • Patients may not be eligible for this study if they:
  • Had a serious illness and have not finished therapy for the illness or become stable on the therapy.
  • Abuse alcohol or drugs.
  • Have taken any nonnucleoside reverse transcriptase inhibitor other than EFV.
  • (This study has been changed. In an earlier version, patients were ineligible if they had taken certain anti-HIV agents or stopped treatment for more than 7 days in a row before the study.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

San Francisco General Hosp

San Francisco, California, 94110, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Rhode Island Hosp

Providence, Rhode Island, 02906, United States

Location

Stanley Street Treatment and Resource

Providence, Rhode Island, 02906, United States

Location

The Miriam Hosp

Providence, Rhode Island, 02906, United States

Location

Comprehensive Care Clinic

Nashville, Tennessee, 37203, United States

Location

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

  • David Haas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 10, 2002

First Posted

January 11, 2002

Last Updated

July 30, 2008

Record last verified: 2005-01

Locations

US(7)