|
A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body Clinical research trials and A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body. A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body  A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body
A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: The concept that all patients with HIV-1 infection require continuous and indefinite antiretroviral therapy (ART) has been questioned. There are both theoretical reasons and supporting empiric evidence that suggest that discontinuing ART should not select for EFV-resistance. In Dupont Protocol 006, antiretroviral-naive patients were randomized to receive EFV, ZDV, and 3TC. This regimen was associated with an excellent and sustained virologic response. It is certain that many patients in this study were able to maintain sustained suppression of HIV-1 RNA to below limits of detection despite missing occasional doses of all medications. Since therapy with ZDV and 3TC alone is unlikely to maintain virologic control, emergence of substantial high-level EFV resistance should have led to virologic failure. The fact that there were relatively few virologic failures in that study provides indirect but strong evidence that simultaneous discontinuation of EFV, ZDV, and 3TC is unlikely to be associated with emergence of EFV resistance. Many individuals discontinue antiretroviral therapy because of adverse effects. This study provides the opportunity to determine whether the virologic response of patients who discontinue antiretroviral therapy will be compromised. Participants will discontinue their EFV. Other antiretroviral drugs in the patients' regimens may be continued for up to three days after the last EFV dose. Patients will not resume EFV or other antiretroviral agents for at least 28 days after stopping EFV, unless the CD4 cell count declines to a level that indicates the need to resume therapy. Throughout the study, patients will have blood drawn on specified days for plasma EFV assays, intracellular NRTI-TP assays, and demonstration of EFV resistance. After patients have been off their antiretrovirals for at least four weeks, they may choose to restart their ART, start a new regimen, or discontinue their ART. Patients who restart their ART need to come to the clinic seven days after restarting to have blood drawn. After plasma EFV assays have been completed and HIV resistance has not been demonstrated, three patients will have a clonal analysis performed.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.)
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
DavidHaas, Study Chair,
Rhode Island Hosp
Providence, Rhode Island, 02906
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
The Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203
United States
San Francisco General Hosp
San Francisco, California, 94110
United States
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
United States
Additional Information:
Study ID Numbers: ACTG A5131;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029341
Other Hiv Infections Studies:
1. A Randomized, Open-Label Study of 800 mg Lopinavir/200 mg Ritonavir QD in Combination with Tenofovir and Emtricitabine vs. 400 mg Lopinavir /100 mg Ritonavir BID in Combination with Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
2. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
3. The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
4. Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
5. A Prospective Double-Blind Study of Retrovir in Early HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
A Study to Demonstrate that Anti-HIV Drug Therapy can be Stopped Without Causing Viral Resistance, and to Characterize Drug Elimination from the Body
|
|
|
|
|
|
|
|
