A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Hydroxyurea (Drug); Efavirenz (Drug); Stavudine (Drug); Didanosine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
David Wohl, Study Chair
Joe Eron, Study Chair
Roy Gulick, Study Chair
Summary
This study will look at different anti-HIV drug regimens to see which works best to keep the
level of HIV (viral load) in the blood as low as possible during maintenance therapy. You
will be assigned randomly (like tossing a coin) to 1 of 3 groups:
Group 1: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Group 2: Didanosine plus
stavudine plus efavirenz (ddI/d4T/EFV). Group 3: This group of patients will remain on their
current drug regimens. This study will last approximately 3 years; you will receive study
medications for the duration of the study.
Anti-HIV drug regimens that include protease inhibitors (PIs) are very good at lowering viral
load. However, some patients have a rise in HIV levels while on PI maintenance. It may be
possible to keep HIV levels low using another class of drugs for maintenance that are easier
to take and less expensive than PIs. If viral load increases while a patient is taking this
second group of drugs, it may be possible to restart the PI drug regimen and again decrease
HIV levels.
Clinical Details
Official title: Phase II Randomized, Open-Label Study of Maintenance of HIV RNA Suppression After Switching to ddI/d4T/HU vs. ddI/d4T/EFV vs. Continuing the Pre-Entry Protease Inhibitor Regimen
Study design: Treatment, Open Label
Detailed description:
Combination antiretroviral therapies using protease inhibitors (PIs) are capable of
suppressing plasma HIV RNA to undetectable levels. However, approximately 10% of patients
who achieve undetectable viral loads will experience a detectable rise in HIV RNA each year.
When HIV replication has been suppressed to very low levels, it may be possible to
consolidate antiretroviral therapy into a simpler and potentially less toxic "maintenance"
regimen without a PI. Such a regimen would ideally be potent enough to continue to maintain
viral suppression but use agents that are better tolerated, more easily salvaged, less
expensive, and/or more convenient than PI-containing regimens. Subsequent rises in HIV
viremia with non-PI maintenance regimens may respond to resumption of the pre-maintenance
PI-containing regimen, extending the use of the potent PI class.
Patients are randomized 1: 1:1 to treatment with ddI/d4T/HU (Arm A) versus ddI/d4T/EFV (Arm B)
versus continuation of the pre-entry PI-containing regimen (Arm C). Viral load is measured
at Weeks 1, 2, 4, 8, 12, 16, 20, and 24, then every 8 weeks for up to 3 years. Upon virologic
failure (plasma HIV RNA greater than or equal to 200 copies/ml), or drug intolerance,
patients on the maintenance regimens (Arms A and B) restart their pre-entry PI-containing
regimen. Patients on Arm C are managed according to best medical judgment of their primary
care provider in the event of virologic failure.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
You may be eligible for this study if you:
- Are at least 13 years old (need consent if under 18).
- Are HIV-positive.
- Are taking your first anti-HIV drug regimen, which must include a PI and at least one
NRTI (nucleoside reverse transcriptase inhibitor) and have been on this regimen for at
least 12 months.
- Have a viral load less than 400 copies/ml for at least 12 months prior to study entry,
and have a viral load less than 50 copies/ml within 60 days of study entry.
- Have a CD4 cell count of at least 200 cells/mm3 within 60 days of study entry.
- Are willing to go back on the drugs you are currently on, if necessary.
- Are willing to use effective methods of birth control during the study and for 3
months after.
Exclusion Criteria
You will not be eligible for this study if you:
- Have taken ddI, d4T, or HU for more than 2 weeks.
- Have taken any NNRTI (non-nucleoside reverse transcriptase inhibitor) for more than 7
days.
- Have ever taken EFV.
- Have received an HIV vaccine within 30 days prior to study entry.
- Have an AIDS-related cancer that requires chemotherapy.
- Have or have had pancreatic disease.
- Are being treated for a significant illness.
- Abuse drugs or alcohol.
- Are pregnant or breast-feeding.
- Are allergic to any study drugs.
- Have received certain medications.
Locations and Contacts
Stanford Univ Med Ctr, Stanford, California 943055107, United States
San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California 951282699, United States
Willow Clinic, Menlo Park, California 94025, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana 46202, United States
Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts 02114, United States
Beth Israel Deaconess - West Campus, Boston, Massachusetts 02215, United States
Univ of Rochester Medical Center, Rochester, New York 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Cornell Univ Med Ctr, New York, New York 10021, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Chelsea Ctr, New York, New York 10021, United States
Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania 19104, United States
Additional Information
Click here for more information about didanosine Click here for more information about stavudine Click here for more information about efavirenz Haga clic aquí para ver información sobre este ensayo clínico en español.
Starting date: July 1998
Last updated: November 28, 2007
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