Completed

FTC vs Lamivudine in Stable Triple Antiretroviral Therapy for HIV-1

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Emtricitabine

+ Lamivudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorTriangle Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1). Arm 1: Replace lamivudine with FTC while continuing on current background regimen. Arm 2: Continue on current lamivudine-containing regimen. Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy. Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen. Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen. Stratum 3: 50-400 copies/ml; PI in treatment regimen. Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen. Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.

NCT00002416
Principal SponsorTriangle Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

390 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

5 inclusion criteria required to participate
Have a viral load below 400 copies/ml.
Are at least 18 years old.
Are HIV-positive.
Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.).
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6 exclusion criteria prevent from participating
Abuse alcohol or drugs.
Are taking hydroxyurea.
Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
Are pregnant or breast-feeding.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Dr Robert Wallace

St. Petersburg, United StatesOpen Dr Robert Wallace in Google Maps

North Shore Univ Hosp

Great Neck, United States
Completed2 Study Centers