Advertisement

Topics

Once Daily 3TC, Efavirenz and ddI for HIV Infection

2014-08-27 03:49:10 | BioPortfolio

Summary

Poor compliance is thought to be a major cause of treatment failure. The TEddI study is a randomised, multi-centre, open-label study in well-controlled treatment-experienced HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral therapy versus continuation of current anti-retroviral regimen delivered at least twice daily.

Description

Rationale: ‘TEddI’ will enable a once-daily treatment strategy to be studied and provide information on effectiveness, patient adherence and quality of life and the tolerability of such regimens.

Hypothesis: The study hypothesis is that an antiretroviral regimen comprising of three agents taken once daily will have higher levels of adherence than a regimen requiring more frequent dosing.

Primary objective: To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomised to receive either a once daily minimum 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.

Secondary objectives: The secondary objectives of the study will include:

- To estimate the proportion of patients with treatment failure where treatment failure is defined as:

- HIV-1 RNA viral load of >400 copies/ml on two consecutive occasions more than one month apart, OR

- Discontinuation of treatment for any reason (where subsequent therapy does not comply with the study regimen change guidelines outlined in section 3.3.3)

- Proportion of patients with plasma HIV-RNA less than 50 copies/ml (using an ultrasensitive assay) at 24 and 48 weeks

- Change from baseline in CD4 cell count at 24 and 48 weeks

- Changes from baseline in subjects’ quality of life at 24 and 48 weeks

- Changes from baseline based on DASS 21 scores at 24 and 48 weeks

- Incidence and severity of adverse events and abnormal laboratory values (grade 3 & 4) at 24 and 48 weeks

- Proportion of patients remaining on assigned treatment Study Design This is a randomised, open-label, multi-centre, prospective, 48-week study comparing a 3 (or more) drug once-daily antiretroviral regimen with any 3 (or more) drug regimen in which at least 1 drug must be taken at least twice daily.

One hundred and twenty (120) subjects will be recruited and randomised in a 1:1 ratio to one of two open-label treatment regimens and will continue to receive randomised treatment until week 24:

Arm 1: (Once daily arm) commence treatment with a once-a-day combination of licensed antiviral medications (such as EFV/ddI/3TC, EFV/3TC/TDF or ATV/3TC/TDF).

Arm 2: (Continuation arm) continue current ART (minimum 3-drugs) dosed twice daily or more frequently

Following week 24, patients will have the option to continue randomised treatment for a further 24 weeks or switch to the once daily treatment arm. In all cases, patients will be followed up for 48 weeks from the baseline visit.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV Infection

Intervention

once daily minimum 3-drug regimen of anti-retroviral medications

Location

407 Doctors
Sydney
New South Wales
Australia
2010

Status

Recruiting

Source

407 Doctors

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:49:10-0400

Clinical Trials [2069 Associated Clinical Trials listed on BioPortfolio]

Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequen...

TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patie...

Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment

Protocol Summary Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and ...

TMC114-TiDP31-C229: This is a Study on the Effectiveness, Safety and Tolerability of Darunavir (DRV), Administered With Low-dose Ritonavir (Rtv) as 800/100 mg Daily Versus 600/100 mg Twice Per Day for HIV-1 Patients Over a 48-week Treatment Period.

The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early ARV...

Incidence of HANA Conditions in HIV-infected Individuals

With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated n...

PubMed Articles [16499 Associated PubMed Articles listed on BioPortfolio]

Recent updates for designing CCR5 antagonists as anti-retroviral agents.

The healthcare system faces various challenges in human immunodeficiency virus (HIV) therapy due to resistance to Anti-Retroviral Therapy (ART) as a consequence of the evolutionary process. Despite th...

Lower Cutoffs for LC-MS/MS Urine Drug Testing Indicates Better Patient Compliance.

Urine drug testing is used by health care providers to determine a patient's compliance to their prescribed regimen and to detect non-prescribed medications and illicit drugs. However, the cutoff leve...

Pharmacological agents preceding a diagnosis of immune thrombocytopenia in adult patients developing the chronic form: A Swedish national register study.

Patients with primary chronic immune thrombocytopenia (cITP) have been reported to use more anti-infective medications, even before diagnosis of immune thrombocytopenia (ITP). The more common use of a...

In Vitro Chondrotoxicity of Nonsteroidal Anti-inflammatory Drugs and Opioid Medications.

A variety of medications are administered to the intra-articular space for the relief of joint pain. While amide-type local anesthetics have been extensively studied, there is minimal information rega...

Targeting a dark excited state of HIV-1 nucleocapsid by anti-retroviral thioesters revealed by NMR.

HIV-1 nucleocapsid (NCp7) is a two Cys2HisCys zinc knuckle (N-Zn and C-Zn) protein that plays a key role in viral replication. Here we characterize NCp7 conformational dynamics by NMR relaxation dispe...

Medical and Biotech [MESH] Definitions

Directions written to discontinue use of PRESCRIPTION DRUGS in order to reduce unnecessary and/or excessive medications (see POLYPHARMACY), DRUG SIDE EFFECTS and ADVERSE DRUG REACTION.

Improper use of drugs or medications outside the intended purpose, scope, or guidelines for use. This is in contrast to MEDICATION ADHERENCE, and distinguished from DRUG ABUSE, which is a deliberate or willful action.

A component of the Executive Office of the President established by the Anti-Drug Abuse Act of 1988. The Office establishes policies, priorities, and objectives for national DRUG AND NARCOTIC CONTROL. The goals of the program are to reduce illicit drug use, manufacturing, and trafficking, drug-related crime and violence, and drug-related health consequences.

Agents used to treat RETROVIRIDAE INFECTIONS.

A condition associated with the use of certain medications and characterized by an internal sense of motor restlessness often described as an inability to resist the urge to move.

More From BioPortfolio on "Once Daily 3TC, Efavirenz and ddI for HIV Infection"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...

Antiretroviral therapy
Standard antiretroviral therapy (ART) consists of the combination of at least three antiretroviral (ARV) drugs to maximally suppress the HIV virus and stop the progression of HIV disease. Huge reductions have been seen in rates of death and suffering whe...


Searches Linking to this Trial