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Isentress Medical Research Studies

Up-to-date List of Isentress Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Isentress Medical Research Studies

Rank Status Study
1 Unknown  Raltegravir Switch for Toxicity or Adverse Events
Conditions: HIV/AIDS;   Antiretroviral Therapy;   HIV Infections
Interventions: Drug: tenofovir emtricitabine raltegravir;   Drug: Lamivudine Abacavir Raltegravir;   Drug: Abacavir free
Outcome Measures: To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure;   Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis;   Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis;   Evolution of CD4 cell count during the 48 weeks of study;   Evolution of adherence and quality of life during the 48 weeks of study;   Evolution of raltegravir plasma concentrations during the 48 weeks of study;   Evolution of metabolic parameters during the 48 weeks of study;   Change of the results of neurocognitive tests at 48 weeks of study;   Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study
2 Recruiting Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
Condition: HIV Infection
Interventions: Drug: Reformulated Raltegravir;   Drug: Raltegravir;   Drug: TRUVADA™;   Drug: Placebo to Reformulated Raltegravir;   Drug: Placebo to Raltegravir
Outcome Measures: Percentage of Participants Achieving <40 copies/mL HIV-1 Ribonucleic Acid (RNA) at Week 48;   Change from Baseline in Cluster of Differentiation (CD4) Cell Count at Week 48;   Percentage of Participants Achieving <40 copies/mL HIV-1 RNA at Week 96;   Change from Baseline in CD4 Cell Count at Week 96;   Percentage of Participants with an Adverse Experience;   Percentage of Participants with a Drug-Related Adverse Experience;   Percentage of Participants with a Serious Adverse Experience;   Percentage of Participants with a Serious and Drug-Related Adverse Experience;   Percentage of Participants Discontinued from Drug Therapy Due to an Adverse Experience
3 Recruiting Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: Raltegravir
Outcome Measures: The number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI;   The cumulative number of new or enlarging T2 weighted lesions on brain MRI;   Change in score on Multiple Sclerosis Functional Composite (MSFC);   Changes in Kurtzke Extended Disability Status Scale (EDSS) score;   Cumulative number of Gd-T1 enhancing lesions;   Percent of subjects with scans free from enhancing lesions in Raltegravir treated subjects vs. baseline
4 Unknown  Effect of Antacids on the Pharmacokinetics of Raltegravir
Condition: HIV Infections
Interventions: Drug: raltegravir;   Drug: antacid (Maalox Plus Extra Strength)
Outcome Measures: Raltegravir AUC with and without an antacid;   Raltegravir Cmax with and without an antacid
5 Not yet recruiting Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
Condition: HIV Infections
Interventions: Drug: Raltegravir (MK-0518);   Drug: Nevirapine;   Drug: Lamivudine;   Drug: Tenofovir;   Drug: Emtricitabine;   Drug: Lopinavir;   Drug: Ritonavir;   Drug: Atazanavir;   Drug: Darunavir
Outcome Measures: Change from Baseline in Renal Function;   Percentage of Participants with Decline in Renal Function at Week 48;   Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48;   Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 RNA) at Week 96;   Percentage of Participants with Decline in Renal Function at Week 96
6 Not yet recruiting Evaluation of Raltegravir During the Third Trimester of Pregnancy
Conditions: HIV-1 Infection;   PREGNANCY
Intervention: Other: Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy
Outcome Measures: Comparison of the AUC and raltegravir trough concentration during and after pregnancy;   Estimation of placental transfer of raltegravir;   Study of genetic polymorphism which could modify raltegravir concentrations;   Proportion of women having a viral load < 50 cp/mL at delivery;   Proportion of maternal-to-child HIV transmission;   Untimely stop of raltegravir for toxicity or intolerance;   Clinical and biological anomaly occurring during the third trimester of pregnancy and during the first 6 months of life of the neonate.;   Estimation of neonatal elimination of raltegravir
7 Unknown  Raltegravir in the Swiss HIV Cohort Study
Condition: HIV Infection
Intervention: Drug: Raltegravir
Outcome Measures: HIV RNA < 50 copies/ml;   durability of HIV RNA suppression;   predictors of HIV RNA suppression (viral load and CD4 at baseline, resistance at baseline for those with detectable HIV RNA, number of active drugs within the salvage regimen;   time course of CD4 lymphocytes;   severe drug-related adverse events;   drug levels of raltegravir and other antiretroviral drugs;   evolution of resistance in patients with virologic failure while on raltegravir
8 Not yet recruiting Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
Conditions: HIV Infection;   Osteopenia
Interventions: Drug: raltegravir and atazanavir and ritonavir;   Drug: tenofovir/emtricitabine and atazanavir and ritonavir
Outcome Measures: Variations from baseline in DEXA-measured bone mineral density (t-score, spine and femur);   variations from baseline in CTX (C-terminal telopeptide of type I collagen) and OC (Osteocalcin);   To assess the variation in renal function
9 Unknown  Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Condition: Healthy Volunteers
Interventions: Drug: raltegravir;   Drug: Placebo
Outcome Measures: Blood levels of total cholesterol;   Changes in HDL, LDL and triglycerides;   Oral glucose tolerance test;   Mitochondrial DNA levels
10 Recruiting Renal Transplantation and Raltegravir in HIV-Infected Patients
Conditions: HIV-1 Infection;   Chronic Renal Insufficiency
Intervention: Drug: Raltegravir
Outcome Measures: Incidence of acute clinical renal graft rejection;   Incidence of acute clinical and subclinical renal graft rejection;   One year graft survival;   Patients' survival;   Phenotyping of lymphocytic infiltrates in case of acute rejection;   Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation;   Immunological and virologic status after renal transplantation;   Evaluation of the switch by raltegravir at the time of renal transplantation;   Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation;   Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation;   Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir
11 Recruiting Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study
Conditions: HIV Infection;   Adverse Drug Reaction;   Quality of Life
Intervention: Drug: Raltegravir switch
Outcome Measures: The proportion of patient-reported clinical adverse events;   The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides);   The proportion of patients with treatment failure;   The proportion of patients who are free of "virological failure";   The change from baseline in CD4 cell counts;   the change from baseline in life quality (based on the MOS-HIV questionnaire)
12 Unknown  Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Conditions: Sleep Disorders;   HIV Infections
Interventions: Drug: Raltegravir for the first 2 weeks;   Drug: Efavirenz for the last 2 weeks;   Drug: Efavirenz for the first 2 weeks;   Drug: Raltegravir for the last 2 weeks
Outcome Measures: Symptoms and neurological side effects of study drugs;   Levels of daytime sleepiness;   Sleep Quality;   Patient preference;   Symptoms of depression, anxiety and stress will be assessed
13 Recruiting Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Condition: HIV-1 Infection
Interventions: Drug: Raltegravir;   Drug: Efavirenz
Outcome Measures: The proportion of patients who can achieve of less than 20 HIV RNA copies per ml at week 48 of both arms.;   The proportion of patients with achievement of less than 400 HIV RNA copies per ml at week 48 for both arms.;   The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.;   The proportion of treatment failure at week 48 for both arms.
14 Unknown  Simplification From Protease Inhibitors to Raltegravir
Condition: HIV Infections
Intervention: Drug: Raltegravir (Use RAL as a simplification strategy)
Outcome Measures: Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD);   CD4 gains, lipid profile, adverse events,;   Drug resistance mutations;   Raltegravir through plasma levels and correlation with virological failure
15 Unknown  Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
Condition: HIV
Intervention: Drug: Raltegravir
Outcome Measures: Episomal HIV cDNA formation;   Markers of immune activation
16 Unknown  Safety and Efficacy of Raltegravir+TDF+3TC in HBV/HIV Co-infected Patients
Conditions: HBV Coinfection;   HIV Infections
Interventions: Drug: raltegravir and tenofovir and lamivudine;   Drug: efavirenz+tenofovir+lamivudine
Outcome Measures: Frequency and severity of adverse events;   Change of plasma HIV-1 RNA levels;   Change of Peripheral blood CD4 cell counts;   Change of plasma HBV-DNA levels;   Change of serum total bilirubin levels(TBI);   Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe);   Emergence of drug resistance mutations, if appropriate;   Paired liver biopsy comparison according to inflammatory activity and fibrosis score;   Change of serum alanine aminotransferase levels (ALT);   Change of serum aspartate aminotransferase levels (AST);   Change of blood urine nitrogen levels (BUN);   Change of serum creatinine levels (SCr);   Change of blood haemoglobin levels (HB);   Change of white blood cell counts (WBC);   Change of blood platelet counts (PLT);   Change of urine protein levels
17 Unknown  Measurement of Plasma and Intracellular Concentrations of Raltegravir
Condition: HIV
Intervention: Drug: Raltegravir
Outcome Measures: Concentrations of RAL in blood cells.;   Concentrations of RAL in blood plasma.;   Pharmacokinetic variability of plasma concentrations of the drug.;   Pharmacokinetic variability of intracellular concentrations of the drug.;   Trough concentrations of the drug when dosed twice daily versus once daily.;   Pharmacokinetics of the drug when dosed twice daily versus once daily.
18 Unknown  Pilot Study of the Impact of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Undetectable Plasma Virus
Condition: HIV Infections
Intervention: Drug: Raltegravir (MK-0518)
Outcome Measures: HIV-1 RNA response: ≥ 1 log decrease in viral load;   Proviral DNA response, HIV-1 sequence variation
19 Unknown  Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment
Condition: HIV Infections
Intervention: Drug: Raltegravir and Atazanavir
Outcome Measures: Evaluation of the proportion of patients who maintain plasma HIV viral load measurements < 400 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir;   Evaluation of the proportion of patients who have plasma HIV viral load measurements <50 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir;   Time to virologic failure (defined as 2 consecutive VL measurements > 400 copies/ml on 2 separate clinic visits within 4 weeks);   Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir;   Assessment of lipid changes after change in regimen;   Determination of incidence, genotypic and phenotypic resistance patterns, in particular to Raltegravir and Atazanavir, in patients in the event of rebound viremia;   Patient adherence to a regimen of Raltegravir and Atazanavir
20 Unknown  Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
Condition: HIV Integrase, HIV Protease.
Interventions: Drug: Raltegravir;   Drug: Darunavir
Outcome Measure:

These studies may lead to new treatments and are adding insight into Isentress etiology and treatment.

A major focus of Isentress research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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