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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine, zidovudine drug combination
Raltegravir Potassium
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

- 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.