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AIDS clinical trials

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NCT ID: NCT00341172 Completed - AIDS Clinical Trials

The Effects of Genetic Differences Among AIDS Patients on Cytomegalovirus Retinitis

Start date: October 26, 2004
Phase:
Study type: Observational

This study will evaluate the role of certain gene variants on the onset and course of cytomegalovirus (CMV) retinitis-a severe infection affecting the eye-in patients with AIDS. Symptoms include blurry vision, eye pain, photophobia, floaters, eye redness, and impaired vision. Left untreated, it can cause blindness. The study is done in collaboration with investigators of the Longitudinal Studies of the Ocular Complications of AIDS (LSOCA) at the Johns Hopkins University School of Medicine. The purpose of the LSOCA study is to learn about how HIV and other infections associated with AIDS and their treatments affect people's eyes and sight. Blood samples previously collected from patients participating in the LSOCA study will be analyzed for gene variants. These differences will then be correlated with the patients' clinical data to try to discover the role of gene differences among patients on the following: susceptibility to CMV and related problems; development and course of CMV; and response to HAART (highly active antiretroviral treatment), particularly in CMV onset and pathology. The study will use blood samples and clinical information previously collected from patients during their participation in LSOCA. The materials will be identified with a numerical code linking the samples and clinical data. No additional procedures will be performed on patients for this study.

NCT ID: NCT00339391 Completed - Stress Clinical Trials

Socioenvironmental Determinants of Psychological Functioning, Mental Health and AIDS in Mali

Start date: August 19, 2001
Phase:
Study type: Observational

This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT) of the Malian National Institute of Public Health Research (INRSP) and the Section on Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting their joint and individual concerns: 1. Effects of occupational complexity on psychological functioning. The project tests a theory derived from previous SSES research demonstrating that in industrialized societies doing relatively self-directed, substantively complex work increases self-directed orientations to self, society and family and promotes effective intellectual functioning. It uses sociological survey methodology to determine the generalizability of this theory to an essentially pre-literate, preindustrial society. 2. Effects of work-related stress on mental health. Earlier SSES work demonstrated that stressful work conditions lead to distress in industrialized societies. This project extends the investigation of these effects to a non-industrialized setting. It also extends the investigation of work-related stress to include work-related migration, resting a hypothesis that relates equally to SSES and CRMT concerns: that individuals from rural ethnic groups with a cultural tradition of work-related migration will show fewer mental health problems when migrating for nontraditional work than those from cultures without such a tradition. Mental health problems are assessed through: a) adaptations of standard survey-based psychological measures of components of distress, b) general and culture-specific survey-based psychiatric screening questions, and c) a psychiatric interview conducted by a CRMT psychiatrist trained in internationally accepted diagnostic procedures and knowledgeable about local cultures. 3. The effects of migration and cultural and socioeconomic factors on AIDS-related knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of knowledge about the nature of AIDS among rural Malians who are relatively isolated from urban oriented sources of information about culturally non-traditional issues. It also examines how socio-cultural background and migration for work affect AIDS related attitudes and self-reported behaviors in an African society where estimates of HIV prevalence are still relatively low (less than 2%), compared to those of other sub-Saharan African countries. Although these prongs are distinguishable, each requires a longitudinal design, a representative sample, extensive information about responders' social and cultural backgrounds, occupational histories, work conditions, and personal orientations and beliefs. Because of their overlapping theoretical approaches and methodological requirements, combining them in one project increases the richness and efficiency of the data collected for each.

NCT ID: NCT00317460 Completed - HIV Infections Clinical Trials

Buprenorphine and Integrated HIV Care

Start date: September 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.

NCT ID: NCT00302822 Completed - HIV Infections Clinical Trials

Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

Start date: April 2006
Phase: Phase 3
Study type: Interventional

HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity. The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment. We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.

NCT ID: NCT00301561 Completed - HIV Infections Clinical Trials

Antiretroviral Treatment Simplified Follow-up Management Assessment (ANRS 12110 STRATALL)

Start date: May 2006
Phase: Phase 3
Study type: Interventional

Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians…), WHO has developed a follow-up approach based on a simplified monitoring. However, this "simplified" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.

NCT ID: NCT00268827 Completed - AIDS Clinical Trials

A Comparison Study of Kaletra Soft-Gel Capsules and Kaletra Tablets in an African American Cohort

Start date: December 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare Kaletra tablets with Kaletra soft-gel capsules to see if there is any change in the side effects you may have and to see how people in the study feel about using the tablets.

NCT ID: NCT00253045 Completed - HIV Clinical Trials

Motivating HIV+ Women: Risk Reduction and ART Adherence

KHARMA
Start date: August 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a group motivational interviewing based intervention will increase adherence to antiretroviral medications and use of risk reduction behaviors.

NCT ID: NCT00227357 Completed - HIV Infections Clinical Trials

The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

BUP
Start date: July 2005
Phase: N/A
Study type: Observational

The goal of this study is to develop and evaluate an innovative model of care to better serve patients who are both HIV-infected and opioid-dependent.

NCT ID: NCT00213083 Completed - HIV Infections Clinical Trials

Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

Start date: April 2004
Phase: Phase 3
Study type: Interventional

The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

NCT ID: NCT00207168 Completed - AIDS Clinical Trials

To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine

Start date: April 2004
Phase: Phase 4
Study type: Interventional

To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.