A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects (KALYINTE)

NCT01045369 Phase 4 COMPLETED

The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.

Details

Lead sponsor	Therapeutic Concepts
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2010-01
Completion	2011-06

Conditions

• HIV Infections

Interventions

• Kaletra and Intelence Tablets

Primary outcomes

• Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48 — At weeks 24 and 48
• Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48 — At weeks 24 and 48

Countries

United States