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Viramune Medical Research Studies

Up-to-date List of Viramune 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 Viramune Medical Research Studies

Rank Status Study
1 Unknown  Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
Conditions: Hiv Infection With Antiretroviral Therapy Indication;   CD4 Below 350/µL or Below 15%
Intervention: Drug: Nevirapine
Outcome Measure: To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks).
2 Recruiting Rifampin and Nevirapine Interactions in Young Children
Conditions: Tuberculosis;   HIV
Intervention:
Outcome Measures: Area under time curve (AUC) of nevirapine;   Number of children with grade 3 or 4 liver enzymes elevations compared to baseline, new onset of skin rash, nausea, vomiting or treatment modification due to drug side effects;   Number of children with nevirapine 12-hour post-dose concentration (C12h) < 3000 ng/mL;   Time to HIV-1 RNA suppression below 50 copies/mL and change in CD4 cell count from baseline;   Peak concentration (Cmax) and concentration at 12-hours (C12h) post-dose of nevirapine
3 Unknown  Influence of Nevirapine on HCV Viral Load
Conditions: HCV Infection.;   HCV Viral Load.
Interventions: Drug: Nevirapine;   Drug: efavirenz, protease inhibitors
Outcome Measure: Changes in HCV viral load
4 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
5 Not yet recruiting Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults (SWAD)
Condition: HIV-1 Infection
Intervention: Drug: Abacavir/Lamivudine/Dolutegravir
Outcome Measures: Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12;   Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24;   Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48;   Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12;   Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24;   Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W36;   Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48;   Percentage of patients with adverse event of any Grade over 12 weeks;   Percentage of patients with adverse event of Grade 3 or 4 over 48 weeks;   CD4 and CD8 measurement;   Serum creatinine and GFR (MDRD) measurement;   Urinary albumine:creatinine ratio measurement;   Fasting lipids measurement;   Plasma concentration of NVP between Week 0 (W0) and Week 2 (W2);   Plasma concentration of dolutegravir between W0 and W12;   CD14 and usCRP measurement over 48 weeks;   Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires;   Plasma concentration of DTG on 24h at D0 and Week 2
6 Unknown  A Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone Maintenance
Conditions: HIV;   HIV Infections
Intervention: Drug: Raltegravir
Outcome Measures: The percentages of patients in both arms who require methadone dose adjustment;The average methadone dose in each arm;   Changes in CD4+ T lymphocyte count and viral load at weeks 24 and 48 from baseline, and the documented opportunistic infections during study period.;   The occurrence of side effects, adherence and retention rates in two treatment arms.
7 Unknown  Pediatric Nevirapine Resistance Study
Conditions: AIDS;   HIV Infections
Intervention: Drug: nevirapine
Outcome Measures: Virologic suppression at 6 months after randomization;   To compare the time to virologic failure up to 18 months post randomization;   to examine the associations between detection of drug resistance mutation and virologic response to treatment;   to compare the toxicity profiles and adherence in the two groups;   to describe the emergence of genotypic resistance in the two groups
8 Not yet recruiting Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir
Condition: HIV
Intervention: Drug: Rilpivirine/Emtricitabine/Tenofovir
Outcome Measures: Explore Efficacy;   HIV RNA levels
9 Recruiting Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected
Conditions: HIV-1 Infection;   Pf Subclinical Parasitemia
Interventions: Drug: Lopinavir/ritonavir;   Drug: Emtricitabine/tenofovir disoproxil fumarate;   Drug: Efavirenz;   Drug: Nevirapine;   Drug: emtricitabine/tenofovir disoproxil fumarate;   Drug: trimethoprim/sulfamethoxazole
Outcome Measures: Plasmodium falciparum (Pf) subclinical parasitemia (SCP) clearance;   Microscopy defined Pf SCP clearance (by batched centralized microscopy) defined by three consecutive negative blood samples;   Time to confirmed Pf SCP clearance where confirmed clearance is defined by PCR < 10 parasites/µL on three consecutive occasions;   Both qualitative (yes/no) and quantitative (gametocytes/µL) Pf gametocyte carriage on Day 15 by PCR;   Pf parasite density (parasites/µL) as determined by PCR on Day 15;   Uncomplicated clinical malaria at any time during the study;   LPV/r-related changes in sequence
10 Recruiting Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction
Condition: HIV
Intervention: Dietary Supplement: Moringa oleifera
Outcome Measures: Area under the plasma concentration time curve (AUC);   clearance (CL)
11 Recruiting Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study)
Conditions: Tuberculosis;   HIV
Interventions: Drug: 8 hourly LPV/r during TB treatment;   Drug: Nevirapine;   Drug: Lopinavir/Ritonavir
Outcome Measure: Area under the concentration time curve (AUC) for rifampicin, isoniazid, pyrazinamide, ethambutol, lopinavir and nevirapine
12 Not yet recruiting A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Antiretroviral Therapy
Conditions: HIV;   Contraception
Intervention: Drug: Etonogestrel
Outcome Measures: Etonogestrel plasma concentrations;   NNRTI plasma concentrations
13 Unknown  Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)
Conditions: NVP Plasma Level;   NVP Related Mutation;   3TC Related Mutation
Intervention: Drug: AZT/3TC 2 weeks after delivery
Outcome Measure: Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation
14 Unknown  Compare to the Safety of Efavirenz and Nevirapine in Treating HIV Positive Patients With Mild Baseline Liver Function Test Impairment, and/or Hepatitis B or Hepatitis C Co-infection
Conditions: HIV Infections;   Liver Toxicity;   Hepatitis Co-infection
Intervention:
Outcome Measure:
15 Recruiting Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-Term Observational Study
Condition: HIV Infections
Interventions: Drug: lopinavir;   Drug: atazanavir;   Drug: efavirenz;   Drug: fosamprenavir;   Drug: darunavir;   Drug: tipranavir;   Drug: ritonavir;   Drug: nevirapine;   Drug: zidovudine;   Drug: lamivudine;   Drug: tenofovir;   Drug: emtricitabine;   Drug: abacavir
Outcome Measure: To evaluate the effect of early-cART on the viral setpoint
16 Unknown  Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV
Condition: HIV Infections
Intervention: Behavioral: cell phone sms text messaging
Outcome Measures: increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%;   HIV positive rates in infants born to mothers in the study;   number of antenatal care visits;   earlier identification and treatment of HIV positive infants;   acceptability fo smsm messages for PMTCT related care
17 Recruiting Antimalarial Pharmacology in Children and Pregnant Women in Uganda
Conditions: Malaria;   HIV
Intervention:
Outcome Measures: Primary outcome measurement is the area under the plasma concentration versus time curve for all drug analytes.;   Malaria reinfection (recrudescence or new infection);   Parasite clearance rate;   AL and ART toxicity
18 Unknown  A Prospective Cohort of Children With HIV Infection
Condition: HIV Infections
Interventions: Drug: Zidovudine, Stavudine, Didanosine, Lamivudine;   Drug: Nevirapine, Efavirenz;   Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir
Outcome Measure: 1. To collect clinical and immunologic data of children treated with HAART 2. To collect clinical outcome data on children with HIV infection 3. To provide the best possible care to children with HIV infection
19 Recruiting Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Populations Using Formula Feeding (PROMISE)
Condition: HIV
Interventions: Drug: Zidovudine (ZDV);   Drug: Nevirapine (NVP);   Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]);   Drug: Lamivudine-Zidovudine (3TC-ZDV);   Drug: Lopinavir-ritonavir (LPV-RTV)
Outcome Measures: Maternal Health Component: Composite endpoint of progression to AIDS-defining illness or death;   Antepartum Component: Confirmed presence of infant HIV infection;   Antepartum Component: Grade 3 or higher toxicity (for women, also selected Grade 2 hematologic, renal, and hepatic adverse events);   Antepartum Component: Obstetrical complications;   Antepartum Component: Adverse pregnancy outcomes (e.g., stillbirth, preterm delivery at less than 37 weeks gestation, low birth weight less than 2,500 grams, and congenital anomalies);   Maternal Health Component: Death;   Maternal Health Component: AIDS-defining illness;   Maternal Health Component: Composite endpoint of progression to AIDS-defining illness, death, or a serious non-AIDS cardiovascular, hepatic, or renal event;   Maternal Health Component: HIV/AIDS-related events;   Maternal Health Component: Cardiovascular or other metabolic events;   Maternal Health Component: Other targeted medical conditions;   Maternal Health Component: Composite endpoint of HIV/AIDS-related event or death;   Maternal Health Component: Composite endpoint of HIV/AIDS-related event or World Health Organization (WHO) Clinical Stage 2 or 3 event;   Maternal Health Component: Composite endpoint of any condition outlined in Appendix IV of the protocol or death;   Maternal Health Component: Tuberculosis;   Maternal Health Component: Toxicity, defined as Grade 3 or greater laboratory results or signs and symptoms and selected Grade 2 renal and hepatic laboratory results;   Maternal Health Component: Viral resistance;   Maternal Health Component: Self-reported adherence;   Maternal Health Component: Quality of life;   Maternal Health Component: Changes in plasma concentrations of inflammatory and thrombogenic markers;   Maternal Health Component: Cost-effectiveness;   Antepartum Component: Infant HIV infection detected by HIV NAT positivity in the birth sample;   Antepartum Component: Overall and HIV-free infant survival;   Antepartum Component: Adherence to the maternal ARV regimen, measured by maternal report;   Antepartum Component: Cost-effectiveness and feasibility of the trial ARV regimens;   Antepartum Component: Maternal and infant viral resistance to the maternal and infant ARV strategies;   Antepartum Component: Antepartum change in HBV DNA viral load (using log HBV DNA) among women with detectable HBV DNA viral loads at baseline and other HBV outcome measures;   Antepartum Component: Maternal HIV RNA less than 400 copies/mL at delivery
20 Recruiting Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
Condition: HIV Infections
Interventions: Drug: Zidovudine (ZDV);   Drug: Nevirapine (NVP);   Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]);   Drug: Lamivudine-Zidovudine (3TC-ZDV);   Drug: Lopinavir-ritonavir (LPV-RTV)
Outcome Measures: Antepartum Component: Confirmed presence of infant HIV infection;   Antepartum Component: Grade 3 or higher toxicity (for women, also selected Grade 2 hematologic, renal, and hepatic adverse events);   Postpartum Component: Confirmed presence of infant HIV infection;   Postpartum Component: Grade 3 or higher adverse events (for women, also selected Grade 2 hematologic, renal, and hepatic adverse events);   Maternal Health Component: Composite endpoint of progression to AIDS-defining illness or death;   Antepartum Component: Obstetrical complications;   Antepartum Component: Adverse pregnancy outcomes (e.g., stillbirth, preterm delivery at less than 37 weeks gestation, low birth weight less than 2,500 grams, and congenital anomalies);   Antepartum Component: Infant HIV infection detected by HIV NAT positivity in the birth sample;   Antepartum Component: Overall and HIV-free infant survival through 24 months of age (in conjunction with infants in the Postpartum Component);   Antepartum Component: Adherence to the maternal antiretroviral (ARV) regimen, as measured by maternal report;   Antepartum Component: Maternal and infant viral resistance to the maternal and infant ARV strategies;   Antepartum Component: Cost effectiveness and feasibility of the trial ARV regimens;   Antepartum Component: Maternal HIV RNA less than 400 copies/mL at delivery;   Antepartum Component: Antepartum change in HBV DNA viral load between Week 8 and baseline levels (using log HBV DNA) among women with detectable HBV DNA viral loads at baseline and other HBV outcome measures;   Postpartum Component: Infant HIV-free survival through 24 months post-delivery;   Postpartum Component: Overall infant survival through 12 and 24 months post-delivery;   Postpartum Component: Adherence to the maternal and/or infant ARV regimens, as measured by maternal report and hair measures;   Postpartum Component: Rates and patterns of maternal and infant resistance to the maternal and infant ARV regimens;   Postpartum Component: Cost-effectiveness and feasibility of the study ARV prophylaxis regimens;   Maternal Health Component: Death;   Maternal Health Component: AIDS-defining illness;   Maternal Health Component: Composite endpoint of progression to AIDS-defining illness, death, or a serious non-AIDS cardiovascular, hepatic, or renal event;   Maternal Health Component: HIV/AIDS-related events;   Maternal Health Component: Cardiovascular or other metabolic events;   Maternal Health Component: Other targeted medical conditions;   Maternal Health Component: Composite endpoint of HIV/AIDS-related event or death;   Maternal Health Component: Composite endpoint of HIV/AIDS-related event or World Health Organization (WHO) Clinical Stage 2 or 3;   Maternal Health Component: Composite endpoint of any condition outlined in Appendix IV of the protocol or death;   Maternal Health Component: Tuberculosis;   Maternal Health Component: Toxicity: Grade 3 or greater laboratory results or signs and symptoms and selected Grade 2 hematologic, renal, and hepatic laboratory results;   Maternal Health Component: Viral resistance;   Maternal Health Component: Self-reported adherence;   Maternal Health Component: Quality of life;   Maternal Health Component: Changes in plasma concentrations of inflammatory and thrombogenic markers;   Maternal Health Component: Cost-effectiveness;   Postpartum Component: Pharmacokinetic parameters of ARV drugs measured in maternal plasma, hair, breast milk, and infant blood (plasma or dried blood spot) samples collected at birth; Weeks 1, 6, 14, and 26; and subsequent visits during breastfeeding;   Postpartum Component: Functional maternal antibody and HIV-envelope binding responses in breast milk and plasma, until cessation of breastfeeding or 18 months postpartum, whichever comes first

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

A major focus of Viramune 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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