A Study to Demonstrate That Anti-HIV Drug Therapy Can be Stopped Without Causing Viral Resistance… (NCT00029341) | Clinical Trial Compass
CompletedPhase 2
A Study to Demonstrate That Anti-HIV Drug Therapy Can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination From the Body
United States36 participants
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.)
Exclusion Criteria
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00029341
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)