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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00046033

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

118

Last updated by the study team

2011-03-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univ of Miami — Miami, Florida, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• NYU/Bellevue — New York, New York, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Univ of Texas, Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.