HIV Infections

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Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors

Trial phase: 
Phase I
Recruitment status: 
Active, not recruiting

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.

Background information
Trial ID: 
NCT00730223
Other unique IDs: 
040062
GM31304
CFAR Discovery Grant
Official title: 

Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors

Detailed description: 

 

Number to be enrolled: 
33 patients

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.

Background information
Other unique IDs: 
080536

Bone Mineral Density Substudy - An Ancillary Study to MTN-003

Recruitment status: 
Not yet recruiting

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).

Background information
Trial ID: 
NCT00729573
Other unique IDs: 
MTN-003B
Official title: 

Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

Detailed description: 

The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo. This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 33 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy. Study visits will occur every 6 months after enrollment.

Number to be enrolled: 
300 patients

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.

Background information
Other unique IDs: 
DAHBR 9A-ASPA
R34 MH072541

Intervention for (Those) Recently Informed of Seropositive Status (IRISS)

Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00720733
Other unique IDs: 
RMH084723A
1RO1MHO84723-01
Official title: 

A Positive Affect Intervention for Those Recently Diagnosed With HIV

Detailed description: 

The study is a randomized controlled trial of a 5-session positive affect skills intervention compared to an attention-matched control condition. Participants will be 200 men and women who have tested positive for HIV within the past 12 weeks. Both intervention and control sessions will be approximately one hour long and will be administered one-on-one by trained facilitators. Both groups will have daily home practice over the 5 weeks of the intervention.

Number to be enrolled: 
200 patients
Acronym: 
IRISS

Differences in Malaria Infection Levels in HIV-Infected Infants and Children Receiving PI- and NNRTI-Based HAART

Trial phase: 
Phase 0
Recruitment status: 
Not yet recruiting

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).

Background information
Trial ID: 
NCT00719602
Other unique IDs: 
IMPAACT P1068s
PACTG P1068s
Official title: 

P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART

Detailed description: 

The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens. This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060.

Number to be enrolled: 
140 patients

Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

Trial phase: 
Phase IV
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00718536
Other unique IDs: 
RALqd-ATV
Official title: 

Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

Detailed description: 

Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (QD) regimens are preferred rather than twice daily (BID) regimens. The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients. Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (UGT1A1)-mediated glucuronidation pathway.

Number to be enrolled: 
15 patients

Cerebrospinal Fluid (CSF) Raltegravir Substudy

Recruitment status: 
Enrolling by invitation

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.

Background information
Trial ID: 
NCT00718029
Other unique IDs: 
MK: 33132
Official title: 

MK: Raltegravir Concentrations in Cerebrospinal Fluid

Detailed description: 

 

Number to be enrolled: 
15 patients

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

Trial phase: 
Phase III
Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00717964
Other unique IDs: 
IIS-CRI-01
Official title: 

A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir Versus NRTIs as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted PI Regimen

Detailed description: 

 

Number to be enrolled: 
34 patients

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.

Background information
Other unique IDs: 
08-251-2
1R01DA022739-01A2
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