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56221. Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)

of Health and Human Services (DHSS), or local recommendations for initiation of antiretroviral therapy (ART). Platelet count must be at least 50,000/microL, hemoglobin at least 8 g/dL, absolute neutrophil count at least 1000/microL, serum creatinine <2.0 mg/dL (154 micromol/L), and SGOT/SGPT (serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase) at most 3 x upper limit of normal at Screening. Other clinical laboratory tests must be within normal limits or clinically acceptable (...) to the investigator. Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study, or must have been surgically sterilized. Female subjects of childbearing potential must have a negative serum beta-hCG (human chorionic gonadotropin) pregnancy test at Screening and a negative urine beta-hCG pregnancy test on Day 1 prior to dosing. Exclusion Criteria: Female subjects of childbearing potential who

2007 Clinical Trials

56222. Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients

the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Age older than 18 years HIV infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated. Women of child-bearing age: negative pregnancy test (...) 2010 Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas: HCV/HIV-coinfected patients Peginterferon alfa-2a Additional relevant MeSH terms: Layout table for MeSH terms Hepatitis Hepatitis A Hepatitis C HIV Infections Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections Retroviridae Infections Sexually

2007 Clinical Trials

56223. Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania

Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study (...) Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania (SDVS2WK) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov

2007 Clinical Trials

56224. Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission

as facilitator of HIV transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited from a community-based organization, an ambulatory care setting, and a dance club. Condition or disease Intervention/treatment Phase Syphilis Other: educational video Not Applicable Detailed Description: The Solomon-four group design was applied to assess the effectiveness of the video in raising syphilis knowledge among participants, while controlling for the influence of the pre-test knowledge (...) Measures : A secondary outcome was the decision to be tested for syphilis and HIV [ Time Frame: 20 minutes ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table

2007 Clinical Trials

56225. Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women

. This manual-driven, gender-specific intervention has proven effective in reducing sexual risk behaviors in both methadone maintenance and outpatient drug-free patients. To date, however, the intervention has not been tested with pregnant drug abusing women who may actually be at increased risk if they stop using condoms or continue drug use during pregnancy. This study will examine SSB, a targeted behavioral HIV prevention and risk reduction intervention in two samples of pregnant drug abusing women (...) behavioral intervention focused on HIV/STD prevention and safer sex negotiation skills Behavioral: Safer Sex Skills Building (SSB) Test the effectiveness of an intervention for reducing sexual risk factors for HIV infection in two samples of pregnant drug-using women. The intervention, Safer Sex Skills Building (SSB)(El Bassel and Schilling (1991, 1992)), is a manual-driven, gender-specific group intervention delivered by mental health counselors. To date, its effectiveness has not been examined

2008 Clinical Trials

56226. TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence. Condition or disease Intervention/treatment Phase HIV Infections HIV-1 Drug: TMC278 Drug: efavirenz Phase 3 Detailed Description: Over the past decade, anti-human immunodeficiency virus (HIV) drugs have been introduced sequentially for use in the clinic. Currently, patients are routinely being treated with 3 or 4 drug combinations including nucleoside/tide analogue reverse transcriptase inhibitors (NRTIs (...) as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load

2007 Clinical Trials

56227. Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection

contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male or female, age ≥ 18 but <65 years Able and willing to provide informed consent. HIV-1 infection documented by any licensed enzyme-linked immunosorbent assay (ELISA) test kit and confirmed by Western Blot at any (...) time prior to or at study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test HIV RNA < 75 copies/ml on a regimen of a) 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and 1 non-nucleoside RTI (NNRTI) OR b) 2 NRTIs and Protease Inhibitor (PI) for at least 24 weeks OR c) 3 NRTIs HIV RNA < 75 copies/ml at screening > 6 months ≥ 400 CD4+ T cells/mm3 (CD4 nadir ≥ 200 cells) Female subjects

2008 Clinical Trials

56228. HIV Non Occupational Post-Exposure Prophylaxis (PEP)

and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. Able to understand the study procedures and willing to sign informed consent Exclusion Criteria: Any active (...) RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Raltegravir Potassium Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Integrase Inhibitors

2008 Clinical Trials

56229. Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women

Institute of Allergy and Infectious Diseases (NIAID): Microbicide HIV Seronegativity Additional relevant MeSH terms: Layout table for MeSH terms Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Anti-Infective Agents Anti-Bacterial Agents Antiviral Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis (...) Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You

2008 Clinical Trials

56230. Diagnosis of Tuberculosis Infection in HIV Co-infected Children

Sponsor: Case Western Reserve University Collaborator: Thrasher Research Fund Information provided by: Case Western Reserve University Study Details Study Description Go to Brief Summary: Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival. The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting (...) TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited. Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB

2007 Clinical Trials

56231. The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects

Posted : May 21, 2014 Sponsor: Imperial College London Collaborator: Boehringer Ingelheim Information provided by (Responsible Party): Imperial College London Study Details Study Description Go to Brief Summary: The purpose of this study is to investigate the possibility of an association between changes in neurocognitive function, as measured by a computerised test battery, and the use of two different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1 infected subjects (...) a Computerised Test Battery, in Treatment Naïve HIV-1 Positive Subjects Commencing Two Different Antiretroviral Regimens Study Start Date : July 2007 Actual Primary Completion Date : December 2012 Actual Study Completion Date : December 2012 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: NRTIs plus NNRTI arm nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone

2007 Clinical Trials

56232. TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

Infections HIV-1 Human Immunodeficiency Virus Type 1 Drug: TMC278 Drug: Efavirenz Phase 3 Detailed Description: Over the past decade, anti-human immunodeficiency virus (HIV) drugs have been introduced sequentially for use in the clinic. Currently, patients are routinely being treated with 3 or 4 drug combinations including nucleoside/tide analogue reverse transcriptase inhibitors (NRTIs/NtRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and/or fusion inhibitors (...) weeks Drug: Efavirenz 600mg once daily for 96 weeks Experimental: TMC278 TMC278 25 mg tablet once daily for 96 weeks Drug: TMC278 25 mg tablet once daily for 96 weeks Outcome Measures Go to Primary Outcome Measures : Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48 [ Time Frame: Week 48 ] Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1

2007 Clinical Trials

56233. Family-Based HIV Prevention for Latinos

project will develop and test an HIV prevention intervention for Latino families. This study will: Conduct a pilot "run-through" of an adapted family-based intervention with three cohorts (about 24 families) to determine the feasibility, acceptability, and appropriateness for the target population. Revise the family-based HIV prevention intervention based on the results of the pilot "run-through" and structured exit interviews. Recruit and randomize 100 families into the Latino family-based HIV (...) Prevention HIV Seronegativity Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

2007 Clinical Trials

56234. A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults

Eligible for Study: 21 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Age 21 - 65 years HIV-1 infection documented by two different rapid tests for HIV-1 antibodies CD4 count >350 cells/ul Viral load< 20,000 copies/mL Normal hematological function Absence of clinically significant renal disease Normal liver function Random glucose < 11.1 mmol/L Normal electrocardiogram Regular attendance at the Wellness Clinic (...) : TICIPS002_RP01 (E295/05) ( Other Grant/Funding Number: Office of Dietary Supplements ) First Posted: October 26, 2007 Last Update Posted: October 10, 2016 Last Verified: October 2016 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Keywords provided by University of Missouri-Columbia: HIV Alternative Medicine Complementary Medicine Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus

2007 Clinical Trials

56235. Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus

: histopathologic examination Phase 2 Detailed Description: OBJECTIVES: Primary To evaluate the safety and tolerability of topical cidofovir in HIV-infected patients with perianal high-grade squamous intraepithelial lesions (HSIL). To estimate the regression rate of perianal HSIL in patients treated with this regimen. Secondary To determine the human papilloma virus (HPV) DNA types and HPV strain variants present in perianal HSIL and normal perianal tissue. To determine if clinical regression of perianal HSIL (...) collection of tumor and normal tissue for histopathological and molecular correlative studies. Punch biopsies are obtained at baseline, after the first course of therapy, and at 6 weeks after completion of therapy. Tissue samples are examined for histopathology, human papilloma virus (HPV)DNA typing, DNA methylation, and gene expression (via RNA microarray analysis and polymerase chain reaction). After completion of study therapy, patients are followed at 6 weeks. Study Design Go to Layout table

2007 Clinical Trials

56236. Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence

, weeks 2 and 3) followed by 2 sessions (40 minutes, weeks 4 and 5) that will be gender-specific to the patient and gender-matched with the study physicians (one female and one male) who will be trained in HIV testing and risk counseling. Sessions will include skill-building in condom use, safer sex negotiation, self-control of triggers and coping skills, didactic materials, and distribution of written material and address self-perception of risk, barriers to risk reduction, and negotiation of a risk (...) -reduction plan. Behavioral: Enhanced Sexual Risk Management management of sexual risk Active Comparator: 2 Standard Sexual Risk Management (SSRM): In SSRM, patients will attend two 10-minute gender non-specific individual educational sessions about HIV/AIDS provided by one of the study physicians who will be trained in HIV testing and risk counseling. Session 1 will coincide with the physician visit at the time of randomization. The patient will receive pre-test counseling at this time and undergo HIV

2007 Clinical Trials

56237. Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults

research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 50 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Good general health with normal hematological, hepatic and renal functions Demonstrated understanding of study Willing to receive HIV test results HIV-1 and -2 uninfected Hepatitis B surface antigen negative Anti-hepatitis C virus (anti-HCV (...) collection will occur. At some visits, HIV testing and pregnancy testing will occur. Once a year for 5 years following study entry, participants will attend a study visit or will be contacted by study staff by telephone or e-mail for follow-up safety and health monitoring. Some participants will also undergo a blood collection at these visits. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized

2008 Clinical Trials

56238. Drug Interaction Between Coartem&#174; and Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients

Ages Eligible for Study: 18 Years to 60 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Age over eighteen years Ability to provide full written informed consent Confirmed diagnosis of HIV infection Exclusion Criteria: Haemoglobin < 8g/dl Liver and renal function tests > 3 times the upper limit of normal Pregnancy Use of known inhibitors or inducers of cytochrome P450 or P-glycoprotein. Use of herbal medications (information will be obtained (...) Drug Interaction Between Coartem® and Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients Drug Interaction Between Coartem® and Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies

2008 Clinical Trials

56239. Evaluation and Monitoring of Patients With HIV Infectionn

Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study is designed to learn more about HIV infection and the conditions associated with it. Patients 18 years of age or older with known or suspected HIV infection may be eligible for this study. Patients may have participated in previous NIH studies. Participants will have periodic physical examinations and blood tests, including evaluations for responses to treatment. Treatment consistent with accepted standard medical (...) Evaluation and Monitoring of Patients With HIV Infectionn Evaluation and Monitoring of Patients With HIV Infectionn - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Evaluation and Monitoring of Patients

2007 Clinical Trials

56240. Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia

deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Confirmed HIV status by local rapid test algorithm Willingness to be randomized to a contraceptive method and continue (...) Keywords provided by University of Alabama at Birmingham: HIV/AIDS Contraception Birth control CD4+ Viral Load T-cell activation B-cell activation Hormonal Intrauterine device Depo Provera Women IUCD treatment naive Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

2008 Clinical Trials

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