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HIV Seropositivity clinical trials

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NCT ID: NCT00381303 Completed - HIV Clinical Trials

GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

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

The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).

NCT ID: NCT00381212 Completed - Clinical trials for Acquired Immunodeficiency Syndrome

A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.

Start date: September 2006
Phase: Phase 1/Phase 2
Study type: Interventional

To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.

NCT ID: NCT00367458 Completed - HIV Clinical Trials

Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy

STATIN
Start date: October 18, 2006
Phase: Phase 2
Study type: Interventional

This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol) on the human immunodeficiency virus (HIV). If not treated, HIV infection causes an incurable, progressive deficiency in the immune system that leads to death, usually from disease that takes advantage of weakened immunity. Previous studies, however, have suggested that if the amount of cholesterol in infected cells is reduced, multiplication of HIV is also reduced. In this study, researchers will examine the HIV viral loads, that is, amount of the virus in the blood. They will evaluate the composition of the strain of the virus that patients carry (HIV genotype), response of the immune system to the virus, and how genes may determine the way in which the drug may or may not work against the strain of virus. Researchers plan to enroll 22 participants, anticipating a study to last 30 weeks for each participant. Patients ages 18 or older with HIV infection, who are not pregnant or breastfeeding, who do not have a known allergy to atorvastatin use, and who have not had a serious illness or infection that required hospitalization within the 30 days before entering the study may be eligible for this study. They will be assigned to random groups: one that to receive atorvastatin and the other to receive a placebo, which has no effect on cholesterol or ability of the HIV infection to multiply. Patients will remain in their groups and treatments for 8 weeks. At the completion of 8 weeks, no matter the study group, all patients will be required to discontinue all study-related medications for 4 weeks. After that period, the study assignments will be switched, so that those previously taking the placebo will take atorvastatin, and vice versa. The study will proceed for another 8 weeks, followed by a period of stopping study-related medications and patients being observed for 4 weeks. Throughout the study, patients will have regularly scheduled visits at the clinic. At those visits there will be collection of blood samples, assessments of symptoms, physical examinations, and questionnaires to complete. Blood tests may require fasting beforehand, and blood samples will be used in standard tests, including those regarding the liver, kidneys, muscles, blood cells, and pregnancy status. Specialized blood tests will determine viral load, effects of the drug on the immune cells, and genetic influence on the drug's effectiveness.

NCT ID: NCT00341302 Completed - Clinical trials for Pregnant HIV Positive Women

A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries

Start date: July 25, 2002
Phase:
Study type: Observational

By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries. Most HIV-infected children are infected by transmission from mother to child during pregnancy, at birth, or through breast milk. Antiretroviral medications, cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to reduce the risk of transmission. This study will determine mother-to-child transmission rates and the effects on infants of exposure to antiretroviral medications and mode of delivery. Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study. HIV-infected women will be evaluated during pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be taken and physical examination given; blood will be collected for laboratory tests. HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history will be taken and physical examination given; blood will be collected for laboratory tests; and growth will be assessed.

NCT ID: NCT00271882 Completed - HIV Infections Clinical Trials

PTSD and Risk Behavior in HIV Positive Female Adolescents

Start date: March 2006
Phase: N/A
Study type: Observational

This is a qualitative study using a purposive sampling methodology to interview HIV-positive female adolescents who have experienced physical and/or sexual abuse. An open-ended, in-depth interview, occurring over one to two sessions, will be conducted with each participant.

NCT ID: NCT00270530 Completed - HIV Infections Clinical Trials

Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia

Start date: November 2002
Phase: Phase 4
Study type: Interventional

Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.

NCT ID: NCT00245531 Completed - Clinical trials for Human Immunodeficiency Virus Positive or Negative

Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs

Start date: August 2004
Phase: N/A
Study type: Observational

The purpose of this study is to understand the effects of decreased functioning of the testes or ovaries on mental performance in males and females using illicit drugs excluding marijuana.

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: NCT00213005 Completed - HIV Infections Clinical Trials

Safety and Acceptability of Carraguard® in HIV Positive Women and Men

Start date: June 2002
Phase: Phase 1
Study type: Interventional

The study objectives were to assess the mucosal safety of Carraguard® gel when applied vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported by female and male participants during the study may be related to the use of Carraguard® gel; and to examine dimensions of the acceptability of, and compliance with, the study and placebo products.

NCT ID: NCT00130819 Completed - HIV Infections Clinical Trials

Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants

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

The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV clinic. The two approaches are: - Case management and referral - participants are managed by a case manager and referred to a specialized drug treatment center where they receive counseling and medications for opioid-dependence (e.g., methadone or buprenorphine); or - Clinic-based treatment - participants receive counseling and treatment with buprenorphine at the HIV clinic.