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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01352715
First received: January 12, 2011
Last updated: December 2, 2015
Last verified: December 2015
Results First Received: October 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited at international AIDS Clinical Trials Group Units. Recruitment occurred between March 13, 2012 (date first participant was randomized) and October 2, 2013 (date last participant was randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
515 were randomized 1:1 to treatment arms A and B.

Reporting Groups
  Description
Arm A: LPV/r Plus RAL

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

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.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.


Participant Flow:   Overall Study
    Arm A: LPV/r Plus RAL     Arm B: LPV/r Plus Best Available NRTIs  
STARTED     260     255  
COMPLETED     215     209  
NOT COMPLETED     45     46  
Death                 3                 3  
Lost to Follow-up                 5                 7  
Withdrawal by Subject                 4                 8  
site closure                 16                 15  
no final visit in closeout period                 15                 12  
major ineligibility                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All 512 participants without a major eligibility violation.

Reporting Groups
  Description
Arm A: LPV/r Plus RAL

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

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.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Total Total of all reporting groups

Baseline Measures
    Arm A: LPV/r Plus RAL     Arm B: LPV/r Plus Best Available NRTIs     Total  
Number of Participants  
[units: participants]
  258     254     512  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     258     254     512  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  40  (8)     38  (8)     39  (8)  
Gender  
[units: participants]
     
Female     134     126     260  
Male     124     128     252  
Race/Ethnicity, Customized  
[units: participants]
     
White Non-Hispanic     0     1     1  
Black Non-Hispanic     164     162     326  
Hispanic (Regardless of Race)     11     9     20  
Asian, Pacific Islander     83     82     165  
Region of Enrollment  
[units: participants]
     
Malawi     56     55     111  
South Africa     52     51     103  
India     80     78     158  
Zimbabwe     24     23     47  
Kenya     24     24     48  
Peru     5     4     9  
Brazil     6     6     12  
Tanzania     8     9     17  
Thailand     3     4     7  
HIV-1 RNA  
[units: log10┬ácopies/mL]
Mean (Standard Deviation)
  4.6  (0.8)     4.5  (0.9)     4.5  (0.8)  
CD4+ T-cell count  
[units: cells/mm^3]
Mean (Standard Deviation)
  178  (170)     182  (160)     180  (165)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cumulative Probability of Virologic Failure by Week 48   [ Time Frame: From study entry to week 48 ]

2.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 48   [ Time Frame: Study entry and week 48 ]

3.  Secondary:   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 ]

4.  Secondary:   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) ]

5.  Secondary:   Number of Participants Discontinuing Randomized Treatment for Toxicity   [ Time Frame: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks) ]

6.  Secondary:   Number of Participants With a New AIDS-defining Events or Death   [ Time Frame: From study entry throughout follow-up (up to 96 weeks) ]

7.  Secondary:   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) ]

8.  Secondary:   Percentage of Time Spent in Hospital   [ Time Frame: From study entry throughout follow-up (up to 96 weeks) ]

9.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications:
[1] Hull M, Moore D, Harris M, et al. A lamivudine (3TC)-based backbone in conjunction with a boosted protease inhibitor (PI) is sufficient to achieve virologic suppression in the presence of M184V mutations. Program and abstracts of the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12-15, 2009; San Francisco, California. Abstract H-916.


Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01352715     History of Changes
Other Study ID Numbers: ACTG A5273
1U01AI068636 ( US NIH Grant/Contract Award Number )
5UM1AI068634 ( US NIH Grant/Contract Award Number )
Study First Received: January 12, 2011
Results First Received: October 29, 2015
Last Updated: December 2, 2015
Health Authority: United States: Federal Government