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HIV Infections clinical trials

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NCT ID: NCT00885482 Completed - HIV Infections Clinical Trials

Atazanavir and Lamivudine for Treatment Simplification

AtLaS
Start date: May 2009
Phase: Phase 4
Study type: Interventional

Objectives of the study: 1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir. 2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

NCT ID: NCT00885287 Completed - HIV Infections Clinical Trials

Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania

InterACT
Start date: July 2009
Phase: Phase 4
Study type: Interventional

As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need concomitant treatment for both infections. Effective combination treatments are available for both malaria (artemisinin-based combination treatments, ACTs) and HIV/AIDS (antiretroviral combination treatments, ARTs), and these treatments are presently recommended for concomitant use by ministries of health in many endemic countries, including Tanzania. However, theoretically some of these drugs may be involved in harmful interactions with each other, as they share common cytochrome enzymes involved in their metabolism. Such interactions could lead to less effective treatments and/or adverse effects, as a consequence of reduced or increased drug levels, respectively. Only little clinical and pharmacological information is however yet available to guide clinicians and policy-makers on this issue. The main aim of the InterACT study in Tanzania is to conduct a series of detailed observational studies of clinical and paraclinical safety, therapeutic efficacy and pharmacokinetic interactions between the currently nationally recommended first-line treatment for malaria, artemether-lumefantrine, and first-line antiretroviral treatments, primarily nevirapine-based combinations, for HIV/AIDS. The studies will be conducted among patients with uncomplicated malaria, who attend the HIV/AIDS Care and Treatment Clinic and Muheza Designated District Hospital in Muheza, north-eastern Tanzania, which is an area characterized by intense transmission of Plasmodium falciparum malaria and with a prevalence of HIV around 8-10%. The study is expected to inform guidelines for the treatment of malaria in patients with HIV/AIDS in Tanzania, and elsewhere.

NCT ID: NCT00884858 Completed - HIV Infections Clinical Trials

Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects

Start date: April 2009
Phase: Phase 4
Study type: Interventional

Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed. Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution. Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur. Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1. With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.

NCT ID: NCT00884793 Completed - HIV Infections Clinical Trials

Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut

PLUS
Start date: September 2008
Phase: N/A
Study type: Interventional

The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load < 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the gut despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have upper and lower endoscopy at baseline (before intensification) and after intensification. These endoscopies will be used to obtain gut tissue and single cells (for CD4+ cells) .

NCT ID: NCT00881699 Completed - HIV Infections Clinical Trials

Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

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

This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.

NCT ID: NCT00879047 Completed - HIV Infections Clinical Trials

Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection

Start date: April 2009
Phase: Phase 1
Study type: Interventional

The proposed studies will examine the extent of pharmacokinetic and pharmacodynamic interactions between alcohol and various antiretroviral therapies in those with HIV/AIDS, HIV/HCV co-infection, mild HCV and healthy subjects.

NCT ID: NCT00878306 Completed - HIV Infections Clinical Trials

Disulfiram Interactions With HIV Medications: Clinical Implications

Start date: November 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether disulfiram might be a safe and effective treatment for cocaine and/or alcohol dependence in patients with HIV disease. This research is designed to characterize the presence or absence of significant drug interactions between disulfiram and HIV medications using standard clinical pharmacology techniques as well as monitor any side effects that might occur when these medications are administered together.

NCT ID: NCT00878098 Completed - HIV Infections Clinical Trials

Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa

Start date: June 1, 2009
Phase:
Study type: Observational

Background: - In some countries, such as South Africa, the pesticide DDT is an important chemical for control of malaria-carrying mosquitoes. However, there is little evidence about the effects that it might have on human health. - DDT has been associated with miscarriage and fetal loss in areas with high levels of exposure, but more research is needed to determine what levels of exposure are associated with loss of pregnancies. Objectives: - To examine the relationship between pre-pregnancy levels of DDT in the blood and the loss of clinically recognized pregnancies. - To conduct a pilot study to evaluate data collection procedures for future research. Eligibility: - Women between 20 and 30 years of age who are not currently pregnant and who reside in villages in the Vhembe District in the northeastern part of South Africa. Design: - Evaluation of eligibility: 1. Short physical examination, with questionnaire about medical history, current living conditions, and daily life. 2. Several blood samples will be taken for study and to test for anemia, elevated lead levels, malaria, syphilis, and human immunodeficiency virus (HIV). - Half of the women will come from villages that are currently being sprayed with DDT, and half will come from villages that are not being sprayed. - Evaluation before and during pregnancy for subjects who become pregnant: 1. Blood and urine test, including urine pregnancy test. 2. Questions about recent menstrual history and sexual activity. 3. Questions about medical history, including treatment for malaria. - Pregnancy follow-up study, including blood draws, will be conducted regardless of whether the pregnancy is carried to term. - Researchers will assess and adjust study parameters as needed.

NCT ID: NCT00877695 Completed - HIV Infections Clinical Trials

Motiv82Change: an HIV Prevention Study for Young Latino Men

Motiv82Change
Start date: August 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).

NCT ID: NCT00877591 Completed - HIV Infections Clinical Trials

Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatment of HIV disease including atazanavir (Reyataz), fosamprenavir (Lexiva), didanosine (Videx), tenofovir (Viread), atazanavir (Reyataz)/ritonavir (Norvir), fosamprenavir (Lexiva)/ritonavir (Norvir), lamivudine (Epivir), or darunavir (please note that we have completed drug interaction studies for buprenorphine with atazanavir, atazanavir/ritonavir, didanosine, tenofovir and lamivudine) at the PI's previous university; for this CHR application only the studies needed to be completed at UCSF/SFGH will be discussed) or tuberculosis(TB) (rifampin or rifabutin) medications (note: supplement application currently pending). Participants are those with opioid dependence who qualify for buprenorphine/naloxone treatment or they are healthy subjects without opioid dependence who participate in pharmacokinetics studies of the antiretroviral medications. A total of 160 such individuals will be enrolled in these studies (please note that the studies have been ongoing at Virginia Commonwealth University for 3 years so that the total number of participants to be recruited at UCSF/SFGH will be about 50 protocol completers). Participants take the HIV or tuberculosis medicine(s) for up to 15 days (depending on the medication(s) administered and ability to schedule blood and urine sampling sessions).