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Human Immunodeficiency Virus clinical trials

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NCT ID: NCT00458302 Completed - HIV Infections Clinical Trials

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

MONET
Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.

NCT ID: NCT00381524 Completed - Clinical trials for Human Immunodeficiency Virus

HIV Prevention in the Primary Care Setting

Start date: June 2004
Phase: N/A
Study type: Interventional

In the third decade of the HIV pandemic, what was once a uniformly and rapidly fatal disease has been transformed into a chronic illness by advances in the understanding of HIV pathogenesis and therapeutics. As a result, HIV-infected individuals are living longer and better lives. This phenomenon, coupled with a continued steady rate of new HIV infections in this country, has led to the highest U.S. HIV prevalence rates since the beginning of the epidemic. In the past, HIV prevention efforts were separate from routine primary care delivery due to multiple factors including stigma and time constraints. Recent events, including increases in sexually transmitted disease (STD) rates among HIV-infected persons and evidence that infected individuals can be super-infected by HIV strains resistant to antiretroviral therapy, have inspired the SPNS program initiative to develop demonstration projects for interventions to reduce risky sexual exposures among HIV-infected patients receiving primary care.

NCT ID: NCT00351702 Completed - Tuberculosis Clinical Trials

Preventive Therapy for Tuberculosis in HIV Infected Persons

Start date: February 2001
Phase: Phase 3
Study type: Interventional

Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons Phase: Phase III trial Population: 650 HIV positive patients without tuberculosis Number of sites: Three 1. Tuberculosis Research centre, Chennai 2. Government General Hospital, Chennai 3. Government Rajaji Hospital, Madurai Study Duration: 36 months Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons Study Design: The study will be a two-armed prospective randomized clinical trial among HIV- positive patients without active tuberculosis. Enrolled patients will be assigned to one of the two unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3 years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be compared in each group. Study Endpoints:The primary end point of the study will be development of tuberculosis and the secondary endpoints will include adverse drug reactions and mortality rate.

NCT ID: NCT00333892 Completed - Clinical trials for Human Immunodeficiency Virus

Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients

Start date: August 2003
Phase: Phase 2
Study type: Observational

To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary HIV infection.

NCT ID: NCT00333736 Completed - Clinical trials for Human Immunodeficiency Virus

Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration

Start date: May 2005
Phase: Phase 2
Study type: Interventional

Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

NCT ID: NCT00333684 Completed - Clinical trials for Human Immunodeficiency Virus

Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid

Start date: December 2004
Phase: Phase 2
Study type: Interventional

Evaluate and record any changes in the Quality of Life and psychological state of the affected study group following treatment with Bio-Alcamid. Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy. Pre-treatment classification and post treatment recording of changes will be performed by, both, the Principal Investigator and the Treatment Specialist and independently by a 'Blinded' Co-Investigator at post treatment Week 12. Safety data for Bio-Alcamid will be collected throughout the duration of the study. Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid.

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: NCT00300573 Terminated - HIV Infections Clinical Trials

Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs

DECLARE
Start date: April 2006
Phase: Phase 2
Study type: Interventional

The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).

NCT ID: NCT00299897 Active, not recruiting - HIV Infections Clinical Trials

SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients

Start date: March 2006
Phase: Phase 2
Study type: Interventional

This is a 28-day, multi-center, placebo-controlled study designed to look at the dose response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of HIV-infected subjects. Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated in the pathogenesis of HIV. It has also been established that drugs of this nature exert an anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus replication. One measurement of an HIV infected person’s risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a “viral load”). This study is designed to see if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will know which dose of the study drug the patient is taking or if he/she is receiving the placebo (a capsule that looks like the study drug but does not contain any active ingredient). Study drug administration will continue for 28 days. At the end of the 28-day study, the patient will be offered testing of his/her virus for resistance to approved drugs (genotype).

NCT ID: NCT00298350 Completed - HIV Clinical Trials

Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.