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NCT ID: NCT03033017 Withdrawn - HIV Clinical Trials

Predictors of Time to Viremia With an Analytic Treatment Interruption

Start date: July 2016
Phase: N/A
Study type: Observational

This is a two-center study of 30 HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years. Participants will be asked to undergo LN and GALT biopsies both before and after a closely monitored analytic treatment interruption (ATI).

NCT ID: NCT02990312 Withdrawn - Hiv Clinical Trials

Impact of Sirolimus and Maraviroc on CCR5 Expression and the HIV-1 Reservoir in HIV-infected Kidney Transplant Recipients

Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this proof of concept, pilot study is to determine whether the unique combination of the human immunodeficiency virus (HIV) co-receptor antagonist, Maraviroc, and the mammalian target of rapamycin (mTOR) inhibitor, Sirolimus, in HIV-infected kidney transplant recipients has an impact on chemokine receptor 5 (CCR5) density, the HIV-reservoir, or rejection of the transplanted kidney. 15 HIV-infected kidney transplant recipients will be recruited and their immunosuppressant regimen will be changed to include an mTOR inhibitor (such as Sirolimus) unless they are already on one. In addition, Maraviroc will be added to their HIV regimen, unless they are already on Maraviroc. Blood will be taken to measure markers of the HIV reservoir, their CCR5 density and expression, and immune activation.

NCT ID: NCT02911740 Withdrawn - HIV Clinical Trials

Additive Benefit of the Urine LAM Test to Current TB Diagnostics in HIV Positive Adults in Panama City, Panama

Start date: November 2017
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013, there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia. In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis based on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients are co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management, which in turn results in unnecessary toxicity, antibiotic resistance, and monetary expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a simple urine dipstick test and evaluating physician response to new diagnostic testing, in order to reduce misdiagnosis and improve health outcomes in the HIV population.

NCT ID: NCT02572505 Withdrawn - HIV Clinical Trials

Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples

PrEP-HIVD
Start date: November 2015
Phase: N/A
Study type: Interventional

Human immunodeficiency virus (HIV) infection has now become a treatable disease and many infected individuals are interested in having a family. Couples in which the man is infected but the woman is HIV-negative (hereafter referred to as HIV-discordant) require medical intervention during procreation to prevent HIV transmission to the female and her child. The current view is that reducing the number of infections involving unprotected intercourse in HIV-discordant couples is a public health issue in the U.S. The safest methods for HIV-discordant couples are insemination using a sperm donor, adoption and remaining childless. However, some couples strongly desire a biologically related child. Fertility clinics in the United States have been resistant to treating HIV-discordant couples, offering only expensive, invasive techniques. This reduces access to care, leading to couples choosing unprotected intercourse to conceive a child. Pre-exposure prophylaxis (PrEP) is a treatment taken by the woman before having unprotected intercourse with an infected man. Truvada has been approved by the Food and Drug Administration (FDA) to reduce the risk of HIV-discordant couples and the Centers for Disease Control and prevention (CDC) has recommended that serodiscordant patients who wish to have a child be counseled on the availability of PrEP. When risks of transmission are minimized, including undetectable HIV in blood and use of PrEP, unprotected intercourse during the fertile period is likely to be a safe option for conceiving a child. The investigators propose to enroll HIV-discordant couples who have been counseled on the safer alternatives of donor insemination, adoption and remaining childless; have been offered referral to a clinic offering sperm washing with insemination or in vitro fertilization (IVF); have been apprised of the risks of using PrEP and one timed intercourse per cycle; and decide to proceed with this method. Couples will be from the population of HIV-discordant patients with a minimal risk of disease transmission as described above. After evaluation for normal fertility and low potential for disease transmission, the couple will receive instruction on timing of the most fertile day of the cycle, and the woman will be given a prescription for the PrEP medication. The woman and any offspring will be followed for 6 months using blood tests to check for evidence of HIV infection.

NCT ID: NCT02544126 Withdrawn - Depression Clinical Trials

Computer-Based Intervention in HIV-Positive Young Adults

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how working with a computer program may affect mood, feelings, overall health, and markers in blood in young adults with HIV.

NCT ID: NCT02468544 Withdrawn - HIV Clinical Trials

Development and Feasibility Testing of a Mobile Phone-Based HIV Primary Care Engagement Intervention

Start date: March 2017
Phase: N/A
Study type: Interventional

This is an open-trial pilot study in which adult methadone maintenance treatment patients who are living with HIV but are not engaged in HIV primary care (i.e., missed appointments, non-adherence to medication) will be recruited to participate in a HIV primary care engagement study. The purpose of this study is to develop and test the feasibility and acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve engagement in HIV primary care among substance abusing populations with HIV.

NCT ID: NCT02438345 Withdrawn - HIV Clinical Trials

PRO 140 for Human Immunodeficiency Virus

Start date: November 2012
Phase: Phase 2
Study type: Interventional

PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO 140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized background antiretroviral regimen (OBR) plus supervised weekly subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy variables will be obtained over the 24 week duration of the study. Safety will be monitored throughout the course of the study.

NCT ID: NCT02357823 Withdrawn - HIV Clinical Trials

Antibodies and Memory Cells Role After Different Pneumococcal Vaccines in HIV Adults

Start date: January 2015
Phase: N/A
Study type: Observational

Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive subjects, representing the leading etiological agent of severe bacterial pneumonia. International guidelines recommend that HIV positive patients aged >=19 years, who are 13-valent conjugate vaccine (PCV13) naïve, should receive a single dose of PCV13. Pneumococcal polysaccharide vaccine 23-valent (PPV23) should be given >=8 weeks after indicated dose of PCV13, and a second dose of PPV23 should be given 5 years later. For those who previously received PPV23, PCV13 should be administered >=1 year after the last PPV23 dose. HIV infection affects humoral immunity both through reduced T-cell help and changes in the B-cell compartment. Neither amount of circulating memory B cells nor their functions are restored by antiretroviral therapy: this may affect antibody mediated immunity, even in well-treated HIV patients. In asplenic childrens a single dose of PCV13 seems sufficient to restore the pool of anti-pneumococcal polysaccharides IgG memory B cells. In adults, it has been reported that a single dose of 7-valent pneumococcal conjugate vaccine induces significant increases in serotype-specific memory B-cell populations, conversely, immunization with PPV23 seems to decrease memory B-cell frequency. However, data on immunological response after PCV13 in HIV positive adults are still scanty and the optimal pneumococcal prophylaxis strategy needs further investigation. Number of PCV13 doses is actually demanded to clinical judgment for each patient; also current Italian indications recommend at least one dose, but till 3 doses seem to be suggested for immunocompromised patients. Present study aims to investigate short and long term immunological response after different standard vaccine schedule and to evaluate pneumococcal nasopharyngeal colonization in vaccinated patients.

NCT ID: NCT02257788 Withdrawn - HIV Clinical Trials

PRO 140 for Human Immunodeficiency Virus Infection

Start date: September 2014
Phase: Phase 2
Study type: Interventional

PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

NCT ID: NCT02176135 Withdrawn - HIV Clinical Trials

Oral Auranofin for Reduction of Latent Viral Reservoir in Patients With HIV Infection

Goldrake
Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of the study is to evaluate the safety of oral auranofin, a gold compound, in patients with HIV infection whose viral load has been suppressed by antiretroviral therapy for no less than 3 years and have a CD4+ cell count over 500 cells/uL