HIV Infections
Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors
To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.
Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid
This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CFS), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.
Bone Mineral Density Substudy - An Ancillary Study to MTN-003
The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).
Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families
This study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members.
Intervention for (Those) Recently Informed of Seropositive Status (IRISS)
An intervention designed to increase positive affect in a population newly diagnosed with HIV will be effective at improving affect and HIV-related outcomes such as mental and physical health, coping and coping resources.
Differences in Malaria Infection Levels in HIV-Infected Infants and Children Receiving PI- and NNRTI-Based HAART
More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other's progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.
Cerebrospinal Fluid (CSF) Raltegravir Substudy
The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid. The hypotheses are:
- Raltegravir concentrations in CSF will be measurable
- Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios.
- Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.
Study of Raltegravir Versus Nucleotide Reverse Transcriptase Inhibitors (NRTIs) as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted Protease Inhibitor (PI) Regimen
The primary purpose of this research study is to evaluate the safety and tolerability of raltegravir 400 mg taken twice a day compared to an NRTI (nucleotide reverse transcriptase inhibitor) backbone, each with a PI (protease inhibitor) boosted with ritonavir based medication regimen, in HIV-1 positive patients. NRTI and PI are two of the categories of medications currently being used to treat HIV.
Healthy Activities for Prize Incentives
In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect size estimates of a contingency management (CM) therapy that focuses on improving health, especially as related to increasing low intensity physical activities, such as walking, resistance training, and stretching. The Healthy Activities for Prize Incentives (HAPI) intervention will be targeted toward and tested within HIV-positive substance abusers who attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot project with 9 patients, the therapy manuals and materials will be adapted and refined. In a Stage 1b controlled trial, we will recruit and randomize 50 substance abusing HIV-positive patients to (a) HAPI plus 12-step facilitation therapy or (b) contingency management for abstinence plus 12-step facilitation therapy. Each intervention will consist of one weekly individual therapy session for 16 weeks. All participants will provide urine and breath specimens twice weekly that will be tested for opioids, cocaine, methamphetamine, marijuana and alcohol. Patients in both conditions will earn the chance to win prizes for submitting drug-negative specimens, and those randomized to the HAPI condition will also earn the chance to win prizes for engaging in healthy activities. Physical activity levels, drug use, psychological symptoms, and subjective and objective indicators of health (body mass index, waist circumference, blood pressure, viral load) will be measured pre-treatment and at months 2 and 4 (post-treatment), as well as at a 7-month (3 months after treatment) follow-up evaluation. Compared to those receiving 12-step facilitation with contingency management for abstinence, we expect that those in the HAPI condition will participate in more physical activities, decrease drug use to a greater extent, evidence reduced depression, and show trends toward improvements in health indices. If effect sizes in at least the small to medium range are noted across all domains, we will consider the therapy appropriate for further evaluation in a Stage 2 therapy development study.
