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HIV Infections clinical trials

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NCT ID: NCT02273947 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Food Effect Study With BMS-955176

Start date: October 23, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

NCT ID: NCT02269917 Completed - Clinical trials for Human Immunodeficiency Virus Type 1

Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

Start date: March 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter [copies/mL]) HIV-1 infected participants.

NCT ID: NCT02266108 Completed - Clinical trials for Human Immunodeficiency Virus

Economic and Social Empowerment To Increase Upwards Mobility Among Women

ESTIMA
Start date: August 1, 2014
Phase: N/A
Study type: Interventional

The proposed research aims to pilot a multi-strategy structural intervention combining community mobilization to promote gender equity alongside an economic intervention (microfinance and business training) in order to reduce gender-based violence and HIV risk among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA: "Economic and Social Empowerment To Increase Upwards Mobility Among Women." The evaluation will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic intervention) or 2) a wait-list control group. For this preliminary work, at 12 months follow-up, we hypothesize that compared to control participants, intervention participants will have: 1) significantly greater economic security (e.g. decreased debt, increased income, decreased number of sex trades) and 2) significantly greater perceived collective power (i.e. collective efficacy) to address gendered power imbalances within social structures and the community. The long-term goal of this program, upon future refinement and large scale implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately, alleviate a multitude of health burdens among women. Furthermore, we expect that such work will highlight the need for HIV prevention initiatives in Mexico, and elsewhere, to more broadly consider women's 'life contexts' - addressing economic and social burdens in women's lives, to reduce the burden of poverty, gender, and HIV, as well as the intersection of these among women.

NCT ID: NCT02264509 Completed - HIV Clinical Trials

Peripheral Arterial Insufficiency Associated With HIV/AIDS

AIHIV
Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to determine the risk factors associated with the occurrence of arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this disease. The estimated prevalence is 10%, similar to that reported in the general population.

NCT ID: NCT02263326 Completed - HIV Infection Clinical Trials

Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure

ASPIRE
Start date: December 2014
Phase: Phase 3
Study type: Interventional

HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24

NCT ID: NCT02256631 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Start date: June 30, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

NCT ID: NCT02251223 Completed - HIV Infections Clinical Trials

Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects

Start date: February 2001
Phase: Phase 1/Phase 2
Study type: Interventional

Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) / ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs. TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine, stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three treatment groups will be enrolled sequentially starting with the highest tipranavir dosage group first and ending with the lowest tipranavir dosage group. Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine, abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared to historical controls. B) To assess the safety of three tipranavir/ritonavir combinations when used in combination with protocol defined antiretrovirals.

NCT ID: NCT02249130 Completed - HIV Infections Clinical Trials

Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

Start date: March 1999
Phase: Phase 2
Study type: Interventional

To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)

NCT ID: NCT02247999 Completed - Cervical Cancer Clinical Trials

Improving Cervical Cancer Screening Among HIV-Infected Women in India

Start date: November 28, 2012
Phase:
Study type: Observational

Background: - Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical cancer are caused by the human papillomavirus (HPV). HPV is more common in women who have the human immunodeficiency virus (HIV). India has one of the highest rates of women who have both cervical cancer and HIV infection. - Cervical cancer can be discovered in early stages by screening for HPV infection. Researchers want to compare new cervical cancer screening tests for HIV-infected women. They also want to know more about how HPV can lead to cervical cancer in HIV-infected women. To do so, they will hold a study to screen HIV-infected women in India. Objectives: - To improve cervical cancer screening methods in HIV-infected women in India. Eligibility: - Women at least 18 years of age who have HIV infection. - Participants will be recruited from HIV-focused health care clinics in Pune and Chennai, India. Design: - Participants will have a physical exam and medical history. They will provide a urine sample and proof of HIV infection. - Participants will have a gynecological exam. This will involve a pelvic exam and Pap smear to collect cells for study. It will also involve a cervical exam to look for precancerous cells. Cervical tissue may be collected. - Participants will also provide a blood sample for testing. - Participants will return in 2 weeks for the test results. If there are signs of precancerous or cancer cells, participants will be referred to a doctor for treatment.

NCT ID: NCT02238314 Completed - HIV Infections Clinical Trials

Exploratory Study of Tipranavir and Ritonavir in Multiple Protease Inhibitor-experienced HIV Patients

Start date: January 1999
Phase: Phase 2
Study type: Interventional

The primary objective was to evaluate the antiviral activity and safety of two regimens of tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in multiple protease-inhibitor-experienced HIV-1 positive patients.