Clinical Trials
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00027339
First received: December 4, 2001
Last updated: May 17, 2012
Last Verified: May 2012
History of Changes
Purpose
Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient's response to anti-HIV therapy.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug : lopinavir/ritonavir Drug : indinavir sulfate Drug : tenofovir disoproxil fumarate Drug : ritonavir Drug : fosamprenavir |
Phase 2 |
Study Type: | Interventional |
Study Design: |
Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
Official Title: | A Phase II Study of the Predictive Value of Pharmacokinetic-Adjusted Phenotypic Susceptibility (C12h/IC50) on Antiretroviral Response to Ritonavir-Enhanced Protease Inhibitors in Subjects With Failure of Previous Protease Inhibitor-Based Regimens |
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Enrollment: | 53 |
Study Completion Date: | June 2005 |
Detailed Description:
Treatment options are limited for HIV infected individuals who have extensive treatment
experience and harbor resistance to antiretrovirals (ARVs) from multiple drug classes.
Increasing the concentration of PIs in a regimen may be one way to provide more substantial
ARV activity. It is uncertain how combining specific PIs with RTV affects viral
susceptibility and ARV effect. The relationship of PI concentration (e.g., Cmin) to virus
susceptibility (IC50) may be a better predictor of treatment outcome than susceptibility
alone. This study will evaluate the predictive value of pharmacokinetic-adjusted phenotypic
susceptibility (C12h/IC50) on ARV response to ritonavir (RTV)-boosted regimens in patients
failing their current PI-containing regimens.
Participants will have blood drawn during a screening visit for phenotypic assay and to
determine viral load. At study entry, participants will discontinue their PIs while
continuing to take their other ARVs. Each participant and his or her doctor will choose to
add one of three RTV-boosted regimens: 1) indinavir (IDV) and RTV; 2) fosamprenavir (FPV) and
RTV; or 3) lopinavir (LPV)/RTV plus additional RTV. Participants will take this regimen for
14 days. On Day 14, patients will have a 12-hour pharmacokinetic evaluation. On Day 15,
patients will add tenofovir disoproxil fumarate (TDF) to their regimens and may choose to
modify their other ARVs while continuing their RTV-boosted therapy. Participants will have
additional study visits at Weeks 4, 8, 16, and 24. Study visits will include a physical exam
and blood and urine tests. Participants will complete adherence questionnaires four times
during the course of the study.
Eligibility
Ages Eligible for Study: | 13 Years and older | |
Sexes Eligible for Study: | All | |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV infected
- Viral load greater than 2500 copies/ml within 60 days of study entry
- On regimen with at least one PI for a total of at least 48 weeks
- On the same PI regimen for at least 90 days prior to study entry
- Decreased susceptibility to two of these three PIs: LPV, APV, and IDV (documented by phenotype within 90 days prior to study entry)
- Have taken a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks anytime in previous treatment history, or have decreased susceptibility to at least two NNRTIs
- Have taken two or more nucleoside reverse transcriptase inhibitors (NRTIs) for at least 12 weeks anytime in previous treatment history
- Agrees to use acceptable methods of contraception
- Weighs 88 lbs or more
Exclusion Criteria:
- Cannot tolerate RTV, APV, FPV, LPV/RTV, or IDV
- Use of HIV vaccines, investigational agents, hydroxyurea, or therapy to affect the immune system within 60 days of study entry
- Serious kidney problems
- Pregnancy or breastfeeding
- Alcohol or drug use that would interfere with the study
- Serious illness that requires treatment or hospitalization (patients stable on therapy
Contacts and Locations
Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.Please refer to this study by its ClinicalTrials.gov identifier: NCT00027339
Locations Show More
United States, California | ||
USC CRS | ||
Los Angeles, California, United States | ||
Stanford CRS | ||
Palo Alto, California, United States, 94305-5107 | ||
UC Davis Medical Center | ||
Sacramento, California, United States, 95814 | ||
Ucsd, Avrc Crs | ||
San Diego, California, United States, 92103 | ||
United States, Colorado | ||
University of Colorado Hospital CRS | ||
Aurora, Colorado, United States, 80262 | ||
United States, Florida | ||
Univ. of Miami AIDS CRS | ||
Miami, Florida, United States | ||
United States, Indiana | ||
Indiana Univ. School of Medicine, Wishard Memorial | ||
Indianapolis, Indiana, United States, 46202 | ||
Methodist Hosp. of Indiana | ||
Indianapolis, Indiana, United States, 46202 | ||
United States, New York | ||
Beth Israel Med. Ctr., ACTU | ||
New York, New York, United States, 10003 | ||
NY Univ. HIV/AIDS CRS | ||
New York, New York, United States, 10016 | ||
United States, North Carolina | ||
Unc Aids Crs | ||
Chapel Hill, North Carolina, United States, 275997215 | ||
Duke Univ. Med. Ctr. Adult CRS | ||
Durham, North Carolina, United States, 27710 | ||
United States, Tennessee | ||
Vanderbilt Therapeutics CRS | ||
Nashville, Tennessee, United States, 37203 | ||
Puerto Rico | ||
Puerto Rico-AIDS CRS | ||
San Juan, Puerto Rico, 00936-5067 | ||
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)Investigators
Study Chair: | Douglas Richman, MD | University of California, San Diego |
Study Chair: | Joseph J. Eron, MD | University of North Carolina, Chapel Hill |
More Information
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) | |
ClinicalTrials.gov Identifier: | NCT00027339 History of Changes | |
Other Study ID Numbers: | A5126 | |
10079 | ||
ACTG A5126 | ||
AACTG A5126 | ||
Study First Received: | December 4, 2001 | |
Last Updated: | May 17, 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1HIV Protease Inhibitors
RNA, Viral
Phenotype
Viral Load
Pharmacokinetics
Treatment Experienced
Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
HIV Protease Inhibitors
Indinavir
Fosamprenavir
Tenofovir
Protease Inhibitors
ClinicalTrials.gov processed this data on December 13, 2019
This information is provided by ClinicalTrials.gov.