NCT01825031 - Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy | Biotech Hunter

Enrollment

1,805

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions

Human Immunodeficiency Virus

Interventions

DRUG

Raltegravir

400mg twice daily for the first 12 weeks only in addition to 3 standard ARVs

DRUG

Fluconazole

100mg once daily for 12 weeks

DRUG

Azithromycin

500mg once daily for 5 days

DRUG

Albendazole

a single dose 400mg

DRUG

Isoniazid

300mg taken immediately in combination with cotrimoxazole

DIETARY_SUPPLEMENT

Ready to Use Supplementary Food

2x92g packets daily of high energy, low protein lipid-based paste for 12 weeks

Trial Locations (8)

Moi University Clinical Research Centre, Eldoret

KEMRI Wellcome Trust Research Programme, Kilifi

University of Malawi, Blantyre

Joint Clinical Research Centre, Fort Portal, Fort Portal

Joint Clinical Research Centre, Gulu, Gulu

Joint Clinical Research Centre, Mbale, Mbale

Joint Clinical Research Centre, Mbarara, Mbarara

University of Zimbabwe Clinical Research Centre, Harare