HIV Infection
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CLINICAL_TRIALS trial_result · 2015-09-17Clinical Trial Update: Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana [NA]
A completed pilot study in Botswana evaluated whether text message reminders can improve adherence to HIV medications.
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FDA approval · 2015-09-17FDA Approved: LAMIVUDINE AND ZIDOVUDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' lamivudine and zidovudine as an original application, a generic fixed-dose combination for HIV-1 infect…
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CLINICAL_TRIALS trial_result · 2015-09-14Clinical Trial Update: Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT) [Phase 3]
Phase 3 trial update from the SOCA studies on Cytomegalovirus retinitis retreatment in HIV/AIDS patients; results for the CRRT have been pos…
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CLINICAL_TRIALS trial_result · 2015-09-10Clinical Trial Update: Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring [Phase 1]
Phase 1 study evaluating safety and pharmacokinetics of a Dapivirine/Maraviroc vaginal ring for HIV prevention.
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CLINICAL_TRIALS trial_result · 2015-09-09Clinical Trial Update: A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents [NA]
Completion and results posting for a South African pilot worksite parenting program designed to prevent HIV infection among adolescents.
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CLINICAL_TRIALS trial_result · 2015-09-07Clinical Trial Update: Induction-maintenance of Lopinavir/r in HIV-infected Subjects [Phase 4]
Phase 4 clinical trial update on an induction-maintenance strategy using lopinavir/ritonavir in HIV-infected subjects; the study status is c…
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CLINICAL_TRIALS trial_result · 2015-09-07Clinical Trial Update: Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing
A completed clinical trial compared Plasma and SMARTplasma antibody tests for detecting HIV and Hepatitis C antibodies.
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CLINICAL_TRIALS trial_result · 2015-09-02Clinical Trial Update: Omega-3 Supplementation in HIV Patients With Therapeutic Lifestyle Change Diet. [Phase 3]
This document reports the completion of a Phase 3 clinical trial evaluating omega-3 fatty acid supplementation in people with HIV on a thera…
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CLINICAL_TRIALS trial_result · 2015-08-28Clinical Trial Update: Cellulose Sulfate and HIV Transmission Among Women [Phase 3]
Phase 3 trial of cellulose sulfate for HIV prevention in women was terminated early due to futility and safety concerns.
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CLINICAL_TRIALS trial_result · 2015-08-28Clinical Trial Update: Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet [Phase 1]
Phase 1 safety and acceptability trial comparing rectal tenofovir gel with oral tenofovir tablets for HIV prevention; the study is completed…
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CLINICAL_TRIALS trial_result · 2015-08-28Clinical Trial Update: HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment [Phase 1, Phase 2]
This clinical trial update reports the completion of Phase 1 and Phase 2 studies evaluating HIV and sexually transmitted infection preventio…
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CLINICAL_TRIALS withdrawal · 2015-08-28Clinical Trial Update: Dolutegravir + Rilpivirine Switch Study (DORISS) [Phase 2, Phase 3]
A Phase 2/3 trial evaluating switching to a dolutegravir + rilpivirine regimen in virologically controlled HIV infection has been withdrawn.
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FDA label_change · 2015-08-26FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)
The FDA approved Janssen's supplemental application for EDURANT (rilpivirine hydrochloride), updating the labeling for the product as reques…
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CLINICAL_TRIALS trial_result · 2015-08-26Clinical Trial Update: Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485) [Phase 2]
A Phase 2 study assessing the efficacy against tuberculosis, safety, and immunogenicity of the MVA85A/AERAS-485 vaccine in HIV-infected adul…
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CLINICAL_TRIALS trial_result · 2015-08-26Clinical Trial Update: Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers [Phase 1]
Phase 1 trial assessing safety and immunogenicity of two HIV vaccines (SeV-G(NP) and Ad35-GRIN) given intranasally and intramuscularly in pr…
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CLINICAL_TRIALS trial_result · 2015-08-26Clinical Trial Update: Durability of Adherence in Self-Management of HIV [NA]
This is an update on a completed clinical trial evaluating the durability of adherence in self-management of HIV; results were posted in 201…
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CLINICAL_TRIALS trial_result · 2015-08-25Clinical Trial Update: Multiple Dose BE Study With Nevirapine 400mg PR Tablets [Phase 1]
Phase 1 multiple-dose bioequivalence study of Nevirapine 400 mg prolonged-release tablets in HIV infection has completed.
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CLINICAL_TRIALS trial_result · 2015-08-21Clinical Trial Update: Energy Expenditure of People Living With HIV/AIDS
This completed clinical trial, sponsored by the University of Sao Paulo General Hospital, evaluated energy expenditure in people living with…
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CLINICAL_TRIALS trial_result · 2015-08-20Clinical Trial Update: The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception [NA]
A completed clinical trial assessed how HIV protease inhibitors affect the pharmacokinetics of oral norethindrone contraception, with result…
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CLINICAL_TRIALS research · 2015-08-20Clinical Trial Update: Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection [Phase 1]
A terminated Phase 1 clinical trial evaluated ibrutinib for relapsed or refractory B-cell non-Hodgkin lymphoma in adults with HIV infection.
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CLINICAL_TRIALS research · 2015-08-18Clinical Trial Update: Text Messaging to Improve HIV Testing Among Young Women in Kenya [NA]
This clinical trial evaluated whether text messaging could increase HIV testing among young women in Kenya, and the study is completed.
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CLINICAL_TRIALS trial_result · 2015-08-17Clinical Trial Update: Tripterygium Wilfordii Hook F (TwHF) Treatment for Immune Non-responders With HIV-1 Infection [Phase 1, Phase 2]
This document provides a clinical trial update on using Tripterygium wilfordii Hook F (TwHF) to treat HIV-1 infection in immune non-responde…
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FDA approval · 2015-08-10FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for STRIBILD (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) from G…
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CLINICAL_TRIALS trial_result · 2015-08-07Clinical Trial Update: Immune Response to Pneumococcal Vaccination in HIV Infected Individuals [EARLY_Phase 1]
A completed early-phase study evaluating immune response to pneumococcal vaccination in HIV-infected individuals.
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CLINICAL_TRIALS trial_result · 2015-08-07Clinical Trial Update: Analysis of Host Genetic Factors in the Occurrence of Anemia and on the Virological Response to a Peg-interferon/Ribavirin Therapy in HIV-HCV Co-infected Patients [NA]
This completed clinical trial analyzed host genetic factors to understand anemia risk and virological response to Peg-interferon plus ribavi…