Phase
Condition
Aids And Aids Related Infections
Hiv/aids
Hiv Infections
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must provide written, voluntary informed consent to participate in thestudy.
Participants must be naive to antiretroviral treatment with HIV RNA greater than orequal to 1,000 copies/mL at screening, and in the investigator's opinion, requireantiretroviral therapy.
Participant's vital signs, physical examination, and laboratory results must notexhibit evidence of acute illness.
Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug.Participants who are on stable maintenance therapy for an opportunistic infection maybe enrolled after consultation with the Sponsor.
Participant does not require and agrees not to take any drugs that are contraindicatedor have significant pharmacokinetic interactions with study drugs during the course ofthe study. Participant agrees not to take any medication during the study, includingover-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, orrecreational drugs without the knowledge and permission of the principal investigator.
Female participants must be either postmenopausal for at least one year, surgicallysterile, or must use a non-hormonal method of birth control that is acceptable to boththe participant and investigator. All female participants must have a urine pregnancytest performed at screening visit and on Day minus 1/baseline, and results of bothtests must be negative. Female participants may not be breastfeeding.
Participants have received no prior treatment with an HIV-1 integrase inhibitor.
Exclusion
Exclusion Criteria:
Participants must not have history of an allergic reaction or significant sensitivityto the study drugs.
Participants may not have an ongoing history of substance abuse or psychiatric illnessthat could preclude protocol adherence.
Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabinebased on the HIV-1 drug resistance genotypic test results at the screening visit.
Participant may not have significant medical history of concomitant illness or diseasethat would adversely affect his/her participating in the study.
Participants may not have received any investigational drug or investigational vaccinewithin 30 days prior to study drug administration.
Participants may not have any of the following abnormal screening results: Hemoglobin <= 8.0 grams/deciliter, absolute neutrophil count <= 750 cells/microliter, Plateletcount <= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvictransaminase [SGPT]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetictransaminase [SGOT]) >= 3.0 x upper limit of normal (ULN), calculated creatinineclearance < 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.
The investigator considers the participant to be an unsuitable candidate for thestudy.
Study Design
Connect with a study center
Site Reference ID/Investigator# 7963
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Site Reference ID/Investigator# 7831
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Site Reference ID/Investigator# 7959
Toronto, Ontario M5B 1L6
CanadaSite Not Available
Site Reference ID/Investigator# 8099
Montreal, Quebec H2L 5B1
CanadaSite Not Available
Site Reference ID/Investigator# 7695
Lyon, 69000
FranceSite Not Available
Site Reference ID/Investigator# 7695
Lyon Cedex 04, 69317
FranceSite Not Available
Site Reference ID/Investigator# 7960
Montpellier, 34295
FranceSite Not Available
Site Reference ID/Investigator# 7960
Montpellier Cedex 5, 34295
FranceSite Not Available
Site Reference ID/Investigator# 7821
Paris, 75014
FranceSite Not Available
Site Reference ID/Investigator# 8063
Paris, 75012
FranceSite Not Available
Site Reference ID/Investigator# 8052
Genoa, 16132
ItalySite Not Available
Site Reference ID/Investigator# 8052
Genova, 16132
ItalySite Not Available
Site Reference ID/Investigator# 7789
Milan, 20127
ItalySite Not Available
Site Reference ID/Investigator# 8051
Perugia, 06156
ItalySite Not Available
Site Reference ID/Investigator# 8050
Rome, 00184
ItalySite Not Available
Site Reference ID/Investigator# 8221
Wroclaw, 50-220
PolandSite Not Available
Site Reference ID/Investigator# 7713
Bayamon, 00959
Puerto RicoSite Not Available
Site Reference ID/Investigator# 7700
Ponce, 00717-1563
Puerto RicoSite Not Available
Site Reference ID/Investigator# 11102
Barcelona, 08041
SpainSite Not Available
Site Reference ID/Investigator# 7689
Barcelona, 8036
SpainSite Not Available
Site Reference ID/Investigator# 7697
Barcelona, 08916
SpainSite Not Available
Site Reference ID/Investigator# 7692
L'Hospitalet de Llobregat, 08907
SpainSite Not Available
Site Reference ID/Investigator# 7691
Madrid, 28046
SpainSite Not Available
Site Reference ID/Investigator# 7693
Madrid, 28041
SpainSite Not Available
Site Reference ID/Investigator# 7698
Madrid, 28006
SpainSite Not Available
Site Reference ID/Investigator# 7690
Seville, 41013
SpainSite Not Available
Site Reference ID/Investigator# 8431
Phoenix, Arizona 85006
United StatesSite Not Available
Site Reference ID/Investigator# 8432
Beverly Hills, California 90211
United StatesSite Not Available
Site Reference ID/Investigator# 8394
Atlantis, Florida 33462
United StatesSite Not Available
Site Reference ID/Investigator# 8393
Fort Pierce, Florida 34982
United StatesSite Not Available
Site Reference ID/Investigator# 8425
Orlando, Florida 32803
United StatesSite Not Available
Site Reference ID/Investigator# 8402
Tampa, Florida 33614
United StatesSite Not Available
Site Reference ID/Investigator# 8396
Vero Beach, Florida 32960
United StatesSite Not Available
Site Reference ID/Investigator# 8395
Atlanta, Georgia 30303
United StatesSite Not Available
Site Reference ID/Investigator# 8429
Decatur, Georgia 30033
United StatesSite Not Available
Site Reference ID/Investigator# 8424
Boston, Massachusetts 02215
United StatesSite Not Available
Site Reference ID/Investigator# 8426
Charlotte, North Carolina 28209
United StatesSite Not Available
Site Reference ID/Investigator# 11461
Huntersville, North Carolina 28078
United StatesSite Not Available
Site Reference ID/Investigator# 8403
Dallas, Texas 75246
United StatesSite Not Available
Site Reference ID/Investigator# 8433
Houston, Texas 77004
United StatesSite Not Available
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