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AIDS clinical trials

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NCT ID: NCT01172704 Completed - HIV Clinical Trials

HIV/AIDS, Severe Mental Illness and Homelessness

Start date: October 2010
Phase: Phase 2
Study type: Interventional

This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are: 1. To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include: - Decreased frequency of risk behaviors (number of partners, number of encounters) - Increased use of barrier precautions and IV needle cleaning - Positive changes in information and motivation, as well as risk behaviors - Increased HIV Counseling and Testing for those who do not know their HIV status 2. To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be: - Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up

NCT ID: NCT01135251 Completed - AIDS Clinical Trials

Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy

Start date: October 2009
Phase: Phase 2
Study type: Interventional

One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only if the previous dose did not cause tolerability problems. The highest reached dose will be maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary evidence of efficacy will be sought by comparing active and placebo group as to the intensity of their pain at study onset and at study end. The pain will be evaluated by the VAS the Total Symptoms Score and the Clinical Global Impression

NCT ID: NCT01106638 Completed - HIV Infections Clinical Trials

A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.

NCT ID: NCT01092611 Completed - AIDS Clinical Trials

Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

Start date: March 22, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination. No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

NCT ID: NCT01092338 Completed - HIV Infections Clinical Trials

Vitamin D Dose Finding Study

Start date: January 2010
Phase: Phase 2
Study type: Interventional

Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.

NCT ID: NCT01084395 Completed - HIV Infections Clinical Trials

Reducing HIV Risk Among Mexican Youth

Start date: September 2002
Phase: N/A
Study type: Interventional

The broad objective of this project is to test the efficacy of a theory-based HIV risk-reduction intervention, which includes both an adolescent component and parental component, designed to reduce the adolescents' risk of sexually transmitted HIV.

NCT ID: NCT01077310 Completed - Clinical trials for Human Immunodeficiency Virus

Alcohol Pharmacotherapy for HIV+ Prisoners

INSPIRE
Start date: August 2010
Phase: N/A
Study type: Interventional

This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.

NCT ID: NCT01075152 Completed - HIV Infections Clinical Trials

Cryptococcal Optimal ART Timing Trial

COAT
Start date: November 2010
Phase: Phase 4
Study type: Interventional

The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

NCT ID: NCT01070017 Completed - HIV Infections Clinical Trials

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

CASA
Start date: February 2010
Phase: Phase 3
Study type: Interventional

Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.

NCT ID: NCT01058694 Completed - HIV Infections Clinical Trials

The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya

CAPS
Start date: June 2007
Phase: N/A
Study type: Interventional

The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.