drugset / Trial / NCT00765271

Abacavir Pharmacokinetic Study in the Absence/Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects

NCT00765271

Phase 1 Completed 29 enrolled St Stephens Aids Trust
RandomizedCrossoverOpen-labelTreatment

Summary

The study is being conducted as we have found that many patients with Human Immunodeficiency Disease (HIV) require a combination of different drugs to treat the HIV infection. Before using different combination of drugs, it is important to do studies to see if the drugs will affect the activity of one another. The study aims to help us understand if darunavir/ritonavir or raltegravir have any effects on levels of abacavir in the blood. The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed, distributed and eliminated from your body) of abacavir in the absence and in the presence of darunavir/ritonavir and raltegravir.

Timeline

Start
2008-05
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abacavir Other / unclassified 600 mg
Comparator Darunavir Small molecule 300 mg
Comparator Raltegravir Other / unclassified 400 mg
Comparator Ritonavir Other / unclassified 100 mg