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

Summary

The study was conducted on people who were taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV drug) but the drugs in this regimen were not doing a good job of fighting their HIV infection.

The main purpose of this study was to compare two other anti-HIV drug regimens to see how well they fight HIV. The study also looked at how well participants tolerate the drug regimens and how safe they are.

The study was designed to determine whether taking the combination of lopinavir/ritonavir (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line therapy: LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI) combination. Testing a regimen that does not include any NRTIs was important because NRTIs may no longer work for patients who received them as part of their first treatment regimen.

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  lead NETWORK

Principal Investigators

• Alberto M La Rosa, MD · Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS

• Ann C Collier, MD · Univ. of Washington Clinical HIV Research Program (CHIRP)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-13

Primary Completion

2014-10-29

Completion

2014-10-29

Countries

• Brazil
• India
• Kenya
• Malawi
• Peru
• South Africa
• Tanzania
• Thailand
• Zimbabwe

Study Locations