MedDataX Logo

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

NCT ID: NCT00135369

Last Updated: 2011-04-25

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

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-07-31

Brief Summary

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

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 frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \<50 copies/mL after switching to a QD regimen.

Related Clinical Trials

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

Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

NCT00005918

HIV Infections
COMPLETED PHASE3

Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

NCT00135382

HIV Infections
COMPLETED PHASE3

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05979311

HIV HIV Infections
ACTIVE_NOT_RECRUITING PHASE3

Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.

NCT00158821

HIV Infections
COMPLETED PHASE3

A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

NCT00363142

HIV Infection Infection, Human Immunodeficiency Virus
COMPLETED PHASE3

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.

HIV Infections

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

stavudine extended-release, lamivudine, efavirenz

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Documented HIV infection
* 18 years of age or older and weigh at least 40 kg
* Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
* Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion Criteria

* Pregnancy, breastfeeding or plans to become pregnant during the study period
* Any prior documented virologic failure to one or more HAART regimens
* Active AIDS-defining opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Hobson City, Alabama, United States

Site Status

Local Institution

Montgomery, Alabama, United States

Site Status

Local Institution

Phoenix, Arizona, United States

Site Status

Local Institution

Little Rock, Arkansas, United States

Site Status

Local Institution

Los Angeles, California, United States

Site Status

Local Institution

Sacramento, California, United States

Site Status

Local Institution

San Mateo, California, United States

Site Status

Local Institution

Torrance, California, United States

Site Status

Local Institution

Denver, Colorado, United States

Site Status

Local Institution

Norwalk, Connecticut, United States

Site Status

Local Institution

Stratford, Connecticut, United States

Site Status

Local Institution

Washington D.C., District of Columbia, United States

Site Status

Local Institution

Fort Lauderdale, Florida, United States

Site Status

Local Institution

Miami, Florida, United States

Site Status

Local Institution

Miami Beach, Florida, United States

Site Status

Local Institution

Pensacola, Florida, United States

Site Status

Local Institution

Tampa, Florida, United States

Site Status

Local Institution

Decatur, Georgia, United States

Site Status

Local Institution

Chicago, Illinois, United States

Site Status

Local Institution

Indianapolis, Indiana, United States

Site Status

Local Institution

New Orleans, Louisiana, United States

Site Status

Local Institution

Baltimore, Maryland, United States

Site Status

Local Institution

Boston, Massachusetts, United States

Site Status

Local Institution

Berkley, Michigan, United States

Site Status

Local Institution

Detroit, Michigan, United States

Site Status

Local Institution

St Louis, Missouri, United States

Site Status

Local Institution

Las Vegas, Nevada, United States

Site Status

Local Institution

Hackensack, New Jersey, United States

Site Status

Local Institution

Jersey City, New Jersey, United States

Site Status

Local Institution

Neptune City, New Jersey, United States

Site Status

Local Institution

Somers Point, New Jersey, United States

Site Status

Local Institution

Manhasset, New York, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

The Bronx, New York, United States

Site Status

Local Institution

Charlotte, North Carolina, United States

Site Status

Local Institution

Huntersville, North Carolina, United States

Site Status

Local Institution

Washington, North Carolina, United States

Site Status

Local Institution

Winston-Salem, North Carolina, United States

Site Status

Local Institution

Philadelphia, Pennsylvania, United States

Site Status

Local Institution

Reading, Pennsylvania, United States

Site Status

Local Institution

Dallas, Texas, United States

Site Status

Local Institution

Galveston, Texas, United States

Site Status

Local Institution

Houston, Texas, United States

Site Status

Local Institution

Annandale, Virginia, United States

Site Status

Local Institution

Hampton, Virginia, United States

Site Status

Local Institution

Seattle, Washington, United States

Site Status

Local Institution

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AI455-135

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
NCT00050895 COMPLETED PHASE3
Dose Optimisation of Stavudine for the Treatment of HIV Infection
NCT02670772 COMPLETED PHASE3
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
NCT05911360 ACTIVE_NOT_RECRUITING PHASE3
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
NCT00053638 COMPLETED PHASE3
A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients
NCT00002426 COMPLETED NA
Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
NCT00004852 COMPLETED PHASE2
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
NCT05630755 ACTIVE_NOT_RECRUITING PHASE3
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
NCT02397096 COMPLETED PHASE3
Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection
NCT00013520 COMPLETED PHASE3
Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
NCT02345226 COMPLETED PHASE3
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
NCT00344760 COMPLETED PHASE4
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
NCT00002369 COMPLETED NA
The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
NCT00001087 COMPLETED PHASE2
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
NCT01199731 TERMINATED PHASE2
A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
NCT00000922 COMPLETED NA
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
NCT01641809 COMPLETED PHASE2
Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
NCT00000903 COMPLETED PHASE3
Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
NCT02603107 COMPLETED PHASE3
The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients
NCT03789968 COMPLETED
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
NCT00002184 COMPLETED PHASE2
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
NCT01815736 COMPLETED PHASE3
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
NCT03472326 TERMINATED PHASE2
The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
NCT00002381 COMPLETED PHASE1
A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
NCT00002442 COMPLETED PHASE2
A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
NCT00036452 COMPLETED PHASE2