Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug Resistance

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if adjusting the dose of lopinavir/ritonavir (LPV/r) has a better effect on lowering HIV viral load (the amount of HIV in the blood) compared to taking the standard FDA-approved LPV/r dose. This study will also compare the safety and tolerability of these two types of dosing.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Amprenavir; Lopinavir; Ritonavir; Saquinavir; Tenofovir

Criteria

Inclusion Criteria:

• HIV-infection

• Viral load >= 5000 copies/ml within 45 days prior to study entry

• Documented reduction in LPV sensitivity based on results obtained within 45 days prior to study entry

• Prior experience with 2 or more NRTIs for at least 6 months each

• At least 12 weeks of stable antiretroviral treatment that includes at least one PI prior to study entry and may include TDF and/or T-20 for 8 weeks or more immediately prior to study entry

• Negative pregnancy test within 14 days prior to study entry

• Agree not to become pregnant or to impregnate and to use an acceptable form of contraception while receiving study drugs and for 4 weeks after stopping study drugs

Exclusion Criteria:

• Pregnant or breast-feeding.

• Certain drugs within 14 days prior to study entry

• Nonnucleoside reverse transcriptase inhibitors (NNRTIs) within 14 days prior to study entry

• History of intolerance to LPV/r, RTV, or TDF and/or their components

• Drug or alcohol use that, in the opinion of the investigator, would interfere with the study

• Require therapy and/or hospitalization due to a serious infection or medical illness that is potentially life-threatening within 14 days prior to study entry

• Any condition that, in the opinion of the investigator, would compromise ability to participate in the study

• Unexplained fever for 7 consecutive days or chronic diarrhea within 30 days prior to study entry

• Cancer requiring chemotherapy

• Any immune system drugs, HIV vaccine, or other experimental therapy within 30 days prior to study entry

• Plan to use any PI other than APV, SQV, or LPV/r in the initial study treatment