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HIV Non Occupational Post-Exposure Prophylaxis (PEP)

2014-08-27 03:33:42 | BioPortfolio

Summary

This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Description

This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

HIV Infections

Intervention

Fixed-dose Formulation of Tenofovir and Raletgravir

Location

Fenway Community Health
Boston
Massachusetts
United States
02115

Status

Recruiting

Source

Fenway Community Health

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:42-0400

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A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants

The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafen...

ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens

In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy ...

SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection

This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with ...

Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)

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Tenofovir Disoproxil Fumarate (DF) Versus Emtricitabine/Tenofovir DF Fixed-Dose in Subjects Resistant to Lamivudine

This study will evaluate the effectiveness, safety, and tolerability of tenofovir DF versus emtricitabine plus tenofovir DF combination treatment in subjects with lamivudine resistance.

PubMed Articles [9736 Associated PubMed Articles listed on BioPortfolio]

Plasma and Intracellular Pharmacokinetics of Tenofovir in Patients Switched from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide.

The aim of the study was to compare the intra-individual plasma and intracellular peripheral blood mononuclear cell (PBMC) pharmacokinetics (PK) of tenofovir (TFV) and its intracellular metabolite, te...

Fixed dose darunavir boosted with cobicistat combined with emtricitabine and tenofovir alafenamide fumarate.

In an era when virological efficacy approaches 100%, novel antiretroviral (ARV) therapies must deliver better tolerability, safety, and convenient coformulated regimens. We review the phase II and III...

Fixed-dose vs free-dose combinations for the management of hypertension-An analysis of 81 958 patients.

Fixed-dose combinations (FDC) have been developed to reduce the pill burden for hypertensive patients. Data on fixed-dose or free-dose (freeDC) ramipril/amlodipine (R/A) or candesartan/amlodipine (C/A...

Potential kidney toxicity from the antiviral drug tenofovir: new indications, new formulations, and a new prodrug.

The antiviral agent tenofovir is highly effective for the treatment of HIV and hepatitis B virus infections, and the older prodrug tenofovir disoproxil fumarate (TDF) is also a component of daily pree...

Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate.

The nucleotide analogues tenofovir and sofosbuvir are considered to have low potential for drug interactions.

Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of emtricitabine and tenofovir that is used as an ANTI-HIV AGENT in the treatment and prevention of HIV INFECTIONS.

A pharmaceutical preparation that contains emtricitabine, rilpivirine and tenofovir disoproxil fumarate. It is used to treat HIV INFECTIONS.

A pharmaceutical preparation of the ANTI-HIV AGENTS elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate that is used in the treatment of HIV INFECTIONS.

Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

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