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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT01352715
• Date of registration: 12/01/2011
• Prospective Registration: Yes
• Primary sponsor: AIDS Clinical Trials Group
• Public title: Study of Options for Second-Line Effective Combination Therapy (SELECT) SELECT
• Scientific title: Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)
• Date of first enrolment: March 13, 2012
• Target sample size: 515
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01352715
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

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

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

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Drug: Emtricitabine/tenofovir disoproxil fumarate

Drug: Abacavir/lamivudine/zidovudine

Drug: Raltegravir

Drug: Abacavir

Drug: Abacavir/lamivudine

Drug: Lamivudine

Drug: Lamivudine/zidovudine

Drug: Lopinavir/ritonavir

Drug: Zidovudine

Primary Outcome(s)

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

Secondary Outcome(s)

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

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

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]

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)]

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)]

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]

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

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

Secondary ID(s)

ACTG A5273

1U01AI068636

5UM1AI068634

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)

Results

• Results available: Yes
• Date Posted: 06/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01352715