HIV Infection
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CLINICAL_TRIALS trial_result · 2012-03-16Clinical Trial Update: Early vs Late Introduction of Antiretroviral Therapy in HIV-infected Patients With Tuberculosis (ANRS 1295 CAMELIA) [Phase 3]
Phase 3 trial CAMELIA compared early versus delayed initiation of antiretroviral therapy in HIV-infected patients with tuberculosis; the stu…
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FDA approval · 2012-03-15FDA Approved: ZIAGEN — Supplemental Application (ViiV Healthcare Company)
FDA approves a supplemental application for ZIAGEN (abacavir sulfate) filed by ViiV Healthcare Company. The action relates to the drug's lab…
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CLINICAL_TRIALS trial_result · 2012-03-15Clinical Trial Update: Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting [NA]
A completed clinical trial in Rwanda comparing the PrePex device to surgical circumcision to enable rapid scale-up of male circumcision for …
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EMA guidance · 2012-03-15European Medicines Agency issues guidance on prevention of HIV transmission for public consultation
EMA announces guidance on preventing HIV transmission for public consultation, outlining recommendations likely related to public health mea…
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FDA approval · 2012-03-14FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for Reyataz (atazanavir) filed by E.R. Squibb & Sons, L.L.C., resulting in a labeling/indication…
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CLINICAL_TRIALS research · 2012-03-14Clinical Trial Update: Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men [NA]
This clinical trial update describes a pilot study to assess the safety and efficacy of Gardasil against human papillomavirus in HIV-infecte…
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CLINICAL_TRIALS trial_result · 2012-03-13Clinical Trial Update: Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women [Phase 2]
Phase 2 trial assessing safety and immune response of an H1N1 influenza vaccine in HIV-infected pregnant women has completed with results po…
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CLINICAL_TRIALS trial_result · 2012-03-09Clinical Trial Update: Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil [Phase 3]
A Phase 3 clinical trial in Brazil tested an HIV prevention intervention among psychiatric patients and has completed.
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CLINICAL_TRIALS trial_result · 2012-03-08Clinical Trial Update: Training Community Members to Deliver HIV Prevention Programs to Urban Youth [Phase 3]
Phase 3 clinical trial evaluating training community members to deliver HIV prevention programs to urban youth; study status is completed.
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CLINICAL_TRIALS research · 2012-03-07Clinical Trial Update: Observational Study of Effect of Radiation Therapy to Immuno Status in HIV-cancer Patients
This document concerns an observational study evaluating how radiation therapy affects immune status and HIV viral load in HIV-positive canc…
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FDA approval · 2012-03-06FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited, enabling continued approval of a generic Zidovudine pr…
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CLINICAL_TRIALS trial_result · 2012-03-06Clinical Trial Update: Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV [Phase 2]
Phase 2 clinical trial evaluating mindfulness-based stress reduction plus education groups for people with HIV. The study is completed and r…
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CLINICAL_TRIALS research · 2012-03-05Clinical Trial Update: Zinc Therapy in HIV Infected Individuals Who Abuse Drugs [NA]
Completed clinical trial evaluating zinc therapy in people with HIV infection who abuse drugs. Sponsor: Florida International University.
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CLINICAL_TRIALS trial_result · 2012-03-01Clinical Trial Update: Drug Use Investigation of Kaletra
A completed clinical trial investigating Kaletra (lopinavir/ritonavir) for HIV infection with results posted in 2012.
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CLINICAL_TRIALS trial_result · 2012-02-29Clinical Trial Update: Study of Vitamin D and Effect on Heart Disease and Insulin Resistance [Phase 2]
Phase 2 study evaluating whether vitamin D affects heart disease risk and insulin resistance in people with HIV and vitamin D deficiency; re…
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CLINICAL_TRIALS withdrawal · 2012-02-29Clinical Trial Update: Safety Study of TXA127 to Elevate CD4+ T-Lymphocyte Counts in HIV-Infected Patients on Stable HAART Therapy [Phase 1]
The HIV study NCT00757250 evaluating TXA127 to raise CD4+ T-cell counts in patients on HAART has been terminated.
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FDA approval · 2012-02-28FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Zidovudine from Aurobindo Pharma Limited. The approval allows continued marketing of the gen…
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CLINICAL_TRIALS trial_result · 2012-02-28Clinical Trial Update: Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-naïve HIV-infected Patients [Phase 2, Phase 3]
Clinical trial update comparing safety of reduced-dose zidovudine versus standard-dose AZT in antiretroviral-naïve HIV-infected patients acr…
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CLINICAL_TRIALS trial_result · 2012-02-24Clinical Trial Update: Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients [Phase 3]
Phase 3 clinical trial evaluating switching HIV-1 patients from nevirapine immediate-release to extended-release regimens; results completed…
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CLINICAL_TRIALS trial_result · 2012-02-24Clinical Trial Update: Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families [NA]
This entry reports the completed status of a clinical trial evaluating a family-based psychoeducation program to improve outcomes for childr…
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CLINICAL_TRIALS trial_result · 2012-02-22Clinical Trial Update: Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C [Phase 3]
Phase 3 trial evaluating pegylated interferon for liver fibrosis in patients co-infected with HIV and hepatitis C; the study is completed.
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FDA approval · 2012-02-17FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie, resulting in changes to its labeling unde…
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FDA approval · 2012-02-17FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)
FDA approves a supplemental NDA for PREZISTA (darunavir) from Janssen Products LP.
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FDA approval · 2012-02-17FDA Approved: REYATAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for Reyataz (atazanavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2012-02-17FDA Approved: VIRACEPT — Supplemental Application (AGOURON)
The FDA approved a supplemental application for Viracept (nelfinavir mesylate) submitted by Agouron.