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HIV-1 clinical trials

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NCT ID: NCT02652260 Completed - HIV-1 Clinical Trials

Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)

Start date: March 4, 2016
Phase: Phase 2
Study type: Interventional

This study aims to evaluate a switch from fixed dose combination (FDC) treatment with ATRIPLA^TM for 12 weeks prior to screening to FDC treatment with Doravirine, Tenofovir, Lamivudine (MK-1439A) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants. The primary hypothesis is that switching from ATRIPLA^TM to Doravirine, Tenofovir, Lamivudine results in a lower proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at Week 12 than continuation of ATRIPLA^TM treatment.

NCT ID: NCT02547844 Completed - HIV-1 Clinical Trials

Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla

Start date: September 2015
Phase: Phase 4
Study type: Interventional

To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.

NCT ID: NCT02513147 Completed - HIV-1 Clinical Trials

HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen

Start date: June 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess changes in viral reservoir after changing IP/r to dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral Therapy (ART).

NCT ID: NCT02275780 Completed - HIV-1 Clinical Trials

Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)

DRIVE-FORWARD
Start date: December 1, 2014
Phase: Phase 3
Study type: Interventional

To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI). Participants will receive double-blind treatment during the 96-week Base Study. Eligible participants in either of the Base Study groups will continue to receive the doravirine-containing regimen open label for an additional 96 weeks in the Study Extension 1. Eligible participants who are deriving benefit will continue in Study Extension 2 to receive the doravirine-containing regimen open label until doravirine becomes locally available or for an additional 96 weeks, whichever comes first. The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be assessed.

NCT ID: NCT02217904 Completed - HIV-1 Clinical Trials

A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)

Start date: September 17, 2015
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5 log (base10) copies/mL.

NCT ID: NCT02202005 Completed - HIV-1 Clinical Trials

Multiple Dose BE Study With Nevirapine 400mg PR Tablets

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals

NCT ID: NCT01968551 Completed - HIV Infections Clinical Trials

Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

Start date: September 3, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.

NCT ID: NCT01771562 Completed - HIV-1 Clinical Trials

Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

Start date: April 2013
Phase: N/A
Study type: Observational [Patient Registry]

The advent of highly active antiretroviral treatment has resulted in the survival into adolescence of an increasing proportion of infants and children with perinatal HIV infection in Senegal. However, the transformation of HIV into a chronic disease needing lifelong antiretroviral treatment (ART) raises new challenges, among others related to a disturbance of glucose metabolism, lipid abnormalities, in addition to the potential effects on children's growth and puberty. Little is known on nutritional and metabolic changes in HIV-infected children on ART in Africa, while implementation of the latest WHO recommendations should eventually lead to an increase in the number of children on ART in this region. Moreover, bio-clinical evolution of untreated children is poorly documented in the African context. It therefore urgently needed to institute a cohort study to evaluate, in the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders and to characterize the risk factors of their occurrence in children and adolescents infected as they move through adolescent into adulthood.

NCT ID: NCT01702090 Completed - HIV-1 Clinical Trials

Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens.

NCT ID: NCT01450605 Completed - HIV-1 Clinical Trials

Korean Post-marketing Surveillance for Reyataz®

Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly