An interventional study of Elvitegravir, Cobicistat, TAF, FTC and Efavirenz, TDF, and 3TC in HIV/AIDS, sponsored by Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic. Withdrawn. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic · Not applicable, Interventional, and Treatment
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Patients with WHO Stage 1 or 2 disease at HIV diagnosis will be randomized in a 1:1 ratio to either the Genvoya group or the EFV-TDF-3TC group. ART will be initiated on the day of HIV diagnosis. Participants who are found to have a contraindication to their assigned treatment regimen will change ART, and be classified as a failure for their assigned treatment arm. Participants in the EFV-TDF-3TC group with CrCl of 30-50 mL/minute, or with baseline mutations that significantly reduce the susceptibility of EFV will switch to Genvoya. Participants in the Genvoya group who are diagnosed with TB after enrollment will be switched to an ART regimen that can be administered with rifampin. If the study physician determines that a treatment change is indicated due to intolerability or side effects, the relevant clinical data will be presented to a safety committee that is blinded to group assignment. The ART regimen will be changed if the safety committee determines that it is indicated, and the participant will be considered a failure to their assigned treatment group. Patients will be followed for 48 weeks.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Complete abstinence from intercourse; Double barrier method, such as male condom/spermicide, male condom/diaphragm, or diaphragm/spermicide; Hormonal plus a barrier method; Intrauterine device (IUD); Male partner sterilization (if participant has only one sexual partner);
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elvitegravir 150mg po QD Cobicistat 150 mg po QD TAF 10 mg po QD FTC 200 mg QD
Drug: Elvitegravir, Cobicistat, TAF, FTC
EFV 600 mg po QD TDF 300 mg po QD 3TC 300 mg po QD
Drug: Efavirenz, TDF, and 3TC
Drug pages: Elvitegravir · Cobicistat · Tenofovir alafenamide · Emtricitabine
Started on day of HIV diagnosis
Started on day of HIV diagnosis
48-week viral suppression
To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level \<200 copies/ml
Time frame: 48 weeks after enrollment
12-week viral suppression
Proportion of participants who are retained in care with a plasma HIV-1 RNA level \<200 copies/ml
Time frame: 12 weeks after enrollment
Baseline resistance to ART medications
Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors
Time frame: Baseline
Change in CD4 count
Median change in CD4 count over the study period (baseline to 48 weeks)
Time frame: 48 weeks after enrollment
Virologic failure
Proportion of patients meeting the WHO definition for ART treatment failure over the study period
Time frame: 48 weeks after enrollment
Adverse events
Proportion of participants with a new Division of AIDS Grade 3 or 4 adverse event or laboratory abnormality that is at least a one-grade increase from baseline
Time frame: 48 weeks after HIV testing
Neurologic or psychiatric adverse event
Proportion of participants with a new Division of AIDS Grade 1 to 4 neurologic or psychiatric disorder that is at least a one-grade increase from baseline
Time frame: 48 weeks
Sleep Quality
Mean scores on the Pittsburgh Sleep Quality Index
Time frame: 4, 12, 24, and 48 weeks after enrollment
Depression
Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire
Time frame: 4, 12, 24, and 48 weeks after enrollment
Change in ART drugs
Proportion of participants who discontinue any drug in the original ART regimen
Time frame: 48 weeks after HIV testing after enrollment
No study locations are listed for this record.
Start is estimated for May 2018; primary completion for May 2020, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Elvitegravir · Cobicistat · Tenofovir alafenamide · Emtricitabine
Acquired Immunodeficiency Syndrome →
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic