A Study to Demonstrate That Anti-HIV Drug Therapy Can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination From the Body

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00029341

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Last updated by the study team

2008-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.)

Where it is running

• San Francisco General Hosp — San Francisco, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Rhode Island Hosp — Providence, Rhode Island, United States
• Stanley Street Treatment and Resource — Providence, Rhode Island, United States
• The Miriam Hosp — Providence, Rhode Island, United States
• Comprehensive Care Clinic — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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