A Phase 4 interventional study of Ritonavir boosted Atazanavir and Raltegravir in Chronic Infection With HIV, sponsored by Pedro Cahn. Status unknown at 2 sites in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Pedro Cahn · Phase 4, Interventional, and Treatment
The purpose of this pilot study is to assess the efficacy and safety of the combination of RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic failure and PI and TDF naïve.
Overall Study Design and Plan: Description
This is a pilot, randomized, open-label study. All the participants will be assigned to receive RAL+ATV/r or TDF/FTC+ATV/r. Patients will be evaluated at screening, randomization (day 0), and on weeks 4, 8, 12, 24, 36 and 48.
At the screening visit, subjects must be willing and able to give written (signed and dated) informed consent prior to any study specific procedures. They will receive a unique screening number and will undergo the study procedures associated with the screening visit. The investigator will evaluate whether the subject meets all eligibility criteria specified and record the details of the informed consent process and the results of this assessment in the subject's medical records. Two forms of the ICF will be signed, one for the subject and the other to file at the site.
At baseline visit, enrollment criteria will be reviewed and subjects who meet all of them will undergo study procedures. Subjects will receive instructions about study medications and dosing schedule. Subjects should start study medication within 24 hours of the baseline visit. Subjects will return to the investigator´s site for study visits and procedures. Subjects who prematurely discontinue the study must return for a discontinuation visit and undergo the study procedures identified for the discontinuation visit.
44 studies on the registry are indexed under Persistent Infection; 5 are open to participants now.
This study's planned enrollment of 50 is below the median of 104 across 28 interventional studies indexed under Persistent Infection.
Browse Persistent Infection studies →Pedro Cahn is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Screening laboratory analysis show any of the following abnormal results:
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.
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).
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 B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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 B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Raltegravir 400 mg BID plus Ritonavir Boosted Atazanavir 300/100 mg QD
Drug: Ritonavir boosted Atazanavir · Drug: Raltegravir
TDF/FTC (or 3TC)- Fixed dose combination of Tenofovir 300 mg plus Emtricitabine 200 mg (or Lamivudine 300 mg) QD plus Ritonavir Boosted Atazanavir 300/100 mg QD
Drug: Ritonavir boosted Atazanavir · Drug: TDF/FTC (or 3TC)
Ritonavir boosted Atazanavir 300/100 mg QD in combination with other drugs
Also known as: Reyataz, Norvir
Raltegravir 400 BID in combination with Ritonavir boosted Atazanavir 300/100 mg QD during 48 weeks
Also known as: Isentress
Drug pages: Tenofovir · Emtricitabine
Fixed dose combination of Tenofovir 300 mg/Emtricitabine 200 mg or Tenofovir 300 mg/Lamivudine 300 mg plus Ritonavir Boosted Atazanavir 300/100mg given once a day
Also known as: Truvada, TDF-FTC, TDF-3TC, Mivuten
Proportion of subjects with plasma HIV-1 RNA below the limit of detection (<50 copies/mL)in an intention to treat (exposed) analysis.
Time frame: 48 weeks
Proportion of subjects with SAEs and proportion with AEs leading to discontinuation.
Time frame: Through week 48
Change from baseline on viral load
Time frame: 24 and 48 weeks
Change from baseline in lipid profile and renal function
Time frame: Through 48 weeks
Change from baseline in inflammation markers
Time frame: 24 and 48 weeks
Number and type of resistance mutations in case of virologic failure
Time frame: Through 48 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of May 2014, a primary completion of Oct 2017 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Raltegravir
Pedro Cahn