Viral and Host Factors in the Transmission and Pathogenesis of HIV
HIV InfectionsTo study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV. The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.
Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for...
HIV InfectionsThe development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.
Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
TuberculosisHuman Immunodeficiency Virus InfectionsTitle: Randomized clinical trial to assess the efficacy of short course intermittent regimens for the treatment of HIV-associated tuberculosis Phase: Phase III trial Population: 300 HIV positive patients with tuberculosis. Number of Sites:Four Tuberculosis Research Centre, Chennai Government General Hospital, Chennai Government Hospital of Thoracic Medicine, Tambaram Government Rajaji Hospital, Madurai Study Duration:36 months Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 / 4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the treatment of pulmonary and extrapulmonary TB in the HIV positive patients. 2. To study the relationship between stage of HIV disease and response to anti-TB treatment. 3. To study recurrences and their nature (relapse/re-infection) in detail by using RFLP analysis. Study Design:It is a two armed prospective randomized open label controlled clinical trial with stratified random allocation based on CD4 count and sputum smear grade. All enrolled patients will be treated according to the RNTCP guidelines during the intensive phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by smear grade, and randomly allocated either to the standard RNTCP regimen, or to an alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).
PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Acquired Immunodeficiency SyndromeRitonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with CD4 counts ≤ 200/mm3.
Safety and Efficacy of T Cell Genetic Immunotherapy for HIV
HIV InfectionThis study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by intravenous infusion of vector modified cells and infusions will be provided every other week for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects will be 18 years of age and over who have failed or are intolerant to at least one triple combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and 200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an AIDS vaccine or any investigational gene therapy product at any time. Females must not be pregnant or breastfeeding.
A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking...
HIV InfectionsThe purpose of this study is to see if certain vitamins (C, E, B1, and B2) can keep lactate levels from becoming too high in patients who are taking nucleoside reverse transcriptase inhibitor (NRTI) anti-HIV drugs. Some patients taking anti-HIV drugs develop hyperlactatemia. Hyperlactatemia is a condition in which lactate (a natural substance normally present in the body) levels are too high. Too much lactate in the body can lead to serious health problems. When patients suffer from hyperlactatemia while taking anti-HIV drugs, most doctors temporarily stop the drugs. Patients then restart the anti-HIV drugs when their lactate levels return to normal. If patients restart the same drugs they were taking when they developed hyperlactatemia, there is a risk that they may develop high lactate levels again. This study wants to find out if taking antioxidants (substances that reduce tissue damage due to oxygen radicals) and certain B vitamins may help prevent patients from developing hyperlactatemia when they restart the same anti-HIV drugs.
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients...
HIV InfectionsThe purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected...
HIV InfectionsThe purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs
HIV InfectionsThe purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients who are taking combination anti-HIV therapy (HAART). This study also examines the effect tucaresol has on viral load (level of HIV in the body) when tucaresol is used with HAART.
Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected...
HIV InfectionsHIV SeronegativityThe purpose of this study is to test the safety and effectiveness of two different formulations of an HIV vaccine in infants born to HIV-infected women.