Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Fosamprenavir; HIV Protease Inhibitors; Indinavir; Lopinavir; Protease Inhibitors; Ritonavir; Tenofovir

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 or who have finished therapy at least 14 days before study entry may be eligible)