Study of Options for Second-Line Effective Combination Therapy (SELECT)

PHASE3CompletedINTERVENTIONAL
Enrollment

515

Participants

Timeline

Start Date

March 13, 2012

Primary Completion Date

October 29, 2014

Study Completion Date

October 29, 2014

Conditions
HIV-1 Infection
Interventions
DRUG

Lopinavir/ritonavir

Lopinavir 400mg/ritonavir 100mg (given as two LPV 200mg/RTV 50mg fixed-dose combination tablets) orally twice daily, with or without food, throughout follow-up.

DRUG

Lopinavir/ritonavir

Lopinavir 400mg/ritonavir 100mg (given as three LPV 133.3 mg/RTV 33.3 mg fixed-dose combination soft gelatin capsules) orally twice daily, with food, throughout follow-up.

DRUG

Raltegravir

Raltegravir 400 mg tablet orally twice daily, with or without food, throughout follow-up.

DRUG

Emtricitabine/tenofovir disoproxil fumarate

Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.

DRUG

Abacavir/lamivudine/zidovudine

Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.

DRUG

Abacavir/lamivudine

Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.

DRUG

Lamivudine/zidovudine

Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.

DRUG

Abacavir

Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily, with or without food, throughout follow-up.

DRUG

Zidovudine

Zidovudine 300 mg tablet orally twice daily, with or without food, throughout follow-up.

DRUG

Lamivudine

Lamivudine 150 mg tablet orally twice daily, with or without food, throughout follow-up.

Trial Locations (16)

21045

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro

30100

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601), Eldoret

50202

Chiang Mai University ACTG CRS (11501), Chiang Mai

411001

BJ Medical College CRS (31441), Pune

Unknown

NARI Pune CRS, Pune

Y.R.G Ctr, for AIDS Research and Education (11701), Chennai

College of Med. JHU CRS (30301), Blantyre

University of North Carolina Lilongwe CRS (12001), Lilongwe

San Miguel CRS, San Miguel

Wits HIV CRS (11101), Johannesburg

Soweto ACTG CRS (12301), Johannesburg

Univ. of Witwatersrand CRS (11101), Johannesburg

Kilimanjaro Christian Medical CRS, Kilimanjaro Region

UZ-Parirenyatwa CRS (30313), Harare

18 PE

Barranco CRS (11301), Lima

4013 SF

Durban Adult HIV CRS (11201), Durban

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT01352715 - Study of Options for Second-Line Effective Combination Therapy (SELECT) | Biotech Hunter | Biotech Hunter