Study of Options for Second-Line Effective Combination Therapy (SELECT) (SELECT)
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ClinicalTrials.gov Identifier: NCT01352715 |
Recruitment Status
:
Completed
First Posted
: May 12, 2011
Results First Posted
: January 6, 2016
Last Update Posted
: January 6, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
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HIV-1 Infection | Drug: Lopinavir/ritonavir Drug: Raltegravir Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Abacavir/lamivudine/zidovudine Drug: Abacavir/lamivudine Drug: Lamivudine/zidovudine Drug: Abacavir Drug: Zidovudine Drug: Lamivudine | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 515 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT) |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
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Experimental: Arm A: LPV/r plus RAL
Participants were administered LPV/r plus RAL orally twice daily throughout follow-up.
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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.
Other Names:
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.
Other Names:
Drug: Raltegravir
Raltegravir 400 mg tablet orally twice daily, with or without food, throughout follow-up.
Other Names:
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Experimental: Arm B: LPV/r plus best available NRTIs
Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs (listed below) throughout follow-up-
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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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
Drug: Abacavir/lamivudine
Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.
Other Names:
Drug: Lamivudine/zidovudine
Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.
Other Names:
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.
Other Names:
Drug: Zidovudine
Zidovudine 300 mg tablet orally twice daily, with or without food, throughout follow-up.
Other Names:
Drug: Lamivudine
Lamivudine 150 mg tablet orally twice daily, with or without food, throughout follow-up.
Other Names:
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- Cumulative Probability of Virologic Failure by Week 48 [ Time Frame: From study entry to week 48 ]The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used.
- Change in CD4+ Cell Count From Baseline to Week 48 [ Time Frame: Study entry and week 48 ]Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.
- Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure [ Time Frame: From study entry through to week 96 ]Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline.
- Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline [ Time Frame: From start of randomized treatment to off randomized treatment (up to 96 weeks) ]The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.
- Number of Participants Discontinuing Randomized Treatment for Toxicity [ Time Frame: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks) ]Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.
- Number of Participants With a New AIDS-defining Events or Death [ Time Frame: From study entry throughout follow-up (up to 96 weeks) ]AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)
- Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death [ Time Frame: From study entry throughout follow-up (up to 96 weeks) ]Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes
- Percentage of Time Spent in Hospital [ Time Frame: From study entry throughout follow-up (up to 96 weeks) ]The percentage of total study time that participants were in hospital.
- Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline [ Time Frame: Study entry and week 48 ]Fasting was for 8 hours and the metabolic panel was drawn locally.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 infected
- Confirmation of first-line virologic failure
- Certain laboratory values obtained within 45 days prior to study entry. More information on this criterion can be found in the study protocol.
- Negative pregnancy test within 48 hours prior to study entry.
- Must refrain from participating in a conception process, and, if participating in sexual activity that could lead to pregnancy, must use at least one acceptable type of contraceptive. More information on this criterion can be found in the study protocol.
- Karnofsky performance score >= 70 within 45 days prior to study entry.
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
- No intention to relocate away from current geographical area of residence for the duration of study participation.
Exclusion Criteria:
- Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days prior to study entry, with the exception of a tapering course of corticosteroids as acute therapy for pneumocystis jiroveci pneumonia (PCP) or acute asthma/chronic obstructive pulmonary disease flare and/or prednisone at a daily dose of <10 mg (physiologic replacement dose).
- If the potential participant has had resistance testing, evidence of broad NRTI cross-resistance that, in the opinion of the investigator, would not allow selection of an effective NRTI combination if the participant were randomized to the LPV/r + best available NRTIs arm.
- Prior exposure to a Protease Inhibitor.
- Known history of congenital long QT syndrome, hypokalemia, or planned use of other drugs that prolong the QT interval.
- Pregnancy or breast-feeding.
- Known history of chronic hepatitis B virus (HBV) infection or current HBV infection defined by the presence of hepatitis B surface antigen in serum or plasma.
- Active tuberculosis (TB) requiring treatment with rifampicin.
- Previously diagnosed malignancies other than basal cell carcinoma and cutaneous Kaposi sarcoma.
- Requirement for taking any medications that are prohibited with the study drugs. More information on this criterion can be found in the study protocol, section 5.4.
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
- Active drug or alcohol use or dependence or other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352715
Brazil | |
Instituto de Pesquisa Clinica Evandro Chagas (12101) | |
Rio de Janeiro, Brazil, 21045 | |
India | |
BJ Medical College CRS (31441) | |
Pune, Maharashtra, India, 411001 | |
NARI Pune CRS | |
Pune, Maharashtra, India | |
Y.R.G Ctr, for AIDS Research and Education (11701) | |
Chennai, India | |
Kenya | |
AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601) | |
Eldoret, Kenya, 30100 | |
Malawi | |
College of Med. JHU CRS (30301) | |
Blantyre, Malawi | |
University of North Carolina Lilongwe CRS (12001) | |
Lilongwe, Malawi | |
Peru | |
San Miguel CRS | |
San Miguel, Lima, Peru | |
Barranco CRS (11301) | |
Lima, Peru, 18 PE | |
South Africa | |
Wits HIV CRS (11101) | |
Johannesburg, Gauteng, South Africa | |
Durban Adult HIV CRS (11201) | |
Durban, South Africa, 4013 SF | |
Soweto ACTG CRS (12301) | |
Johannesburg, South Africa | |
Univ. of Witwatersrand CRS (11101) | |
Johannesburg, South Africa | |
Tanzania | |
Kilimanjaro Christian Medical CRS | |
Kilimanjaro Region, Moshi, Tanzania | |
Thailand | |
Chiang Mai University ACTG CRS (11501) | |
Chiang Mai, Thailand, 50202 | |
Zimbabwe | |
UZ-Parirenyatwa CRS (30313) | |
Harare, Zimbabwe |
Study Chair: | Alberto M La Rosa, MD | Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS | |
Study Chair: | Ann C Collier, MD | Univ. of Washington Clinical HIV Research Program (CHIRP) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AIDS Clinical Trials Group |
ClinicalTrials.gov Identifier: | NCT01352715 History of Changes |
Other Study ID Numbers: |
ACTG A5273 1U01AI068636 ( U.S. NIH Grant/Contract ) 5UM1AI068634 ( U.S. NIH Grant/Contract ) |
First Posted: | May 12, 2011 Key Record Dates |
Results First Posted: | January 6, 2016 |
Last Update Posted: | January 6, 2016 |
Last Verified: | December 2015 |
Additional relevant MeSH terms:
Ritonavir Lopinavir Tenofovir Lamivudine Raltegravir Potassium Emtricitabine Zidovudine Abacavir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine, zidovudine drug combination Dideoxynucleosides HIV Protease Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Integrase Inhibitors Integrase Inhibitors Antimetabolites |