Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Safety Study Comparing 2 Doses of NVP After Initiating Rifampin-containing TB Therapy

NCT00476853

HIV Infections Tuberculosis

COMPLETED PHASE2

CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes

NCT00966160

Acquired Immunodeficiency Syndrome HIV Infections

COMPLETED PHASE3

Genotype Based Personalized Prescription of Nevirapine

NCT00986063

Nevirapine Induced Rash Nevirapine Induced Hepatitis HIV +3 more

COMPLETED PHASE4

Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens

NCT00627055

HIV Infections

COMPLETED PHASE4

Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

NCT01989910

HIV-1 Infection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment Failure, HIV or AIDS CD4 Cell Counts

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simultaneous interruption (Exposure gr)

stopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens

Efavirenz-based regimens

Intervention Type DRUG

Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.

Naive (Control group)

HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.

Efavirenz-based regimens

Intervention Type DRUG

Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.

staggered interruption (exposure group)

after having allergic reactions to NVP-based regimens, stopped NNRTIs first, continued the other NRTIs for a period of time, i.e. "staggered interruption", and later started EFV-based regimens

Efavirenz-based regimens

Intervention Type DRUG

Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Efavirenz-based regimens

Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stocrin, Sustiva

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 18-70 years old
* documented HIV infection
* started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute

Exclusion Criteria

* previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients
* previously received protease inhibitor-based regimen
* diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No