A Phase IV 48-Week, Randomized, Open-Label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy With 3TC/ZDV (or d4T) +/- Protease Inhibitor(s)

NCT00005018 Phase 4 COMPLETED

The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir \[ABC\] plus efavirenz \[EFV\] plus didanosine \[ddI\]) with and without hydroxyurea (HU).

Details

Lead sponsor	Glaxo Wellcome
Phase	Phase 4
Status	COMPLETED
Enrolment	150
Start date	1999-07
Completion	2000-10

Conditions

• HIV Infections

Interventions

• Hydroxyurea
• Abacavir sulfate
• Efavirenz
• Didanosine

Countries

United States