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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00029341 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Behavioral: Treatment Interruption |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Efficacy Study |
Official Title: | A Phase II Study to Demonstrate That Therapy With Efavirenz (EFV) and Other Antiretroviral Drugs Can Be Interrupted Without Selecting for EFV-Resistant Virus, and Relation to Kinetics of Drug Elimination |
Estimated Enrollment: | 36 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients may not be eligible for this study if they:
United States, California | |
San Francisco General Hosp | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Rhode Island | |
The Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
Rhode Island Hosp | |
Providence, Rhode Island, United States, 02906 | |
Stanley Street Treatment and Resource | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
Comprehensive Care Clinic | |
Nashville, Tennessee, United States, 37203 |
Study Chair: | David Haas |
Study ID Numbers: | ACTG A5131 |
Study First Received: | January 10, 2002 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00029341 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Drug Administration Schedule Drug Resistance, Microbial Genotype Reverse Transcriptase Inhibitors |
Anti-HIV Agents Viral Load Pharmacokinetics Efavirenz Treatment Interruption |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |