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HIV Infections clinical trials

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NCT ID: NCT00213044 Completed - HIV Infections Clinical Trials

A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women

Start date: March 2003
Phase: Phase 1
Study type: Interventional

Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited from general medical clinics, family planning clinics, groups/organizations working with persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had to be abstinent or in a seroconcordant relationship with only one partner for the study period.

NCT ID: NCT00213031 Completed - HIV Infections Clinical Trials

Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide

Start date: February 2000
Phase: Phase 2
Study type: Interventional

The primary aims of the study were to assess the safety and acceptability of PC-515 when applied vaginally at least three times weekly for 12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV, and other STIs. The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women would find Carraguard acceptable. The study was not powered to determine effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 trial.

NCT ID: NCT00213018 Completed - HIV Infections Clinical Trials

Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission

Start date: October 1999
Phase: Phase 2
Study type: Interventional

The primary aims of the study were to assess the safety and acceptability of Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV. The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; that women would find Carraguard acceptable. The study was not powered to determine effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy trial.

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: NCT00212940 Completed - HIV Infections Clinical Trials

Supportive Therapy for Adherence to ART(STAART)

Start date: October 2000
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence.

NCT ID: NCT00212888 Completed - HIV Infections Clinical Trials

Combination Vaccination Before HIV Treatment Interruption

Start date: April 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.

NCT ID: NCT00209313 Completed - HIV Infections Clinical Trials

Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon

Start date: March 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.

NCT ID: NCT00207948 Terminated - HIV Infections Clinical Trials

Optimizing Antiretroviral Therapy in HIV-Infected Children and Adolescents

Start date: November 2004
Phase: Phase 4
Study type: Observational

This was a feasibility study aimed at elevating protease inhibitors (PI) dosage as a part of active antiretroviral therapy (HAART). After the pharmacokinetics for the currently prescribed PI were determined,patients with a vIQ<1 were eligible for a 50% dose increase for an 8 week time frame after which their vIQ would be reassessed to determine if increasing their PI dosage thereby increasing the bioavaiability would reduce their viral load.

NCT ID: NCT00207506 Completed - HIV Infections Clinical Trials

Lay Health Advisors for Sexually Transmitted Disease Prevention

Start date: October 2004
Phase: Phase 1/Phase 2
Study type: Interventional

Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.

NCT ID: NCT00207142 Completed - HIV Infections Clinical Trials

Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)

INDUMA
Start date: November 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.