Suspended

Emtricitabine vs. Abacavir in Triple Drug Combination for HIV-1 Treatment

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

Abacavir sulfate

+ Efavirenz

+ Emtricitabine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 1999
See protocol details

Summary

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

Study start date: August 1, 1999

Actual date on which the first participant was enrolled.

Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.

NCT00002362
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.

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
Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms)
Are HIV-positive and generally healthy
Are age 18 or older
Have CD4 cell counts of 200 cells/mm3 or more
Show More Criteria
8 exclusion criteria prevent from participating
Are being treated for active tuberculosis (TB)
Are pregnant or breast-feeding
Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail)
Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain
Show More Criteria

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 10 locations

Ctr for AIDS Research / Education and Service (CARES)

Sacramento, United StatesOpen Ctr for AIDS Research / Education and Service (CARES) in Google Maps

San Francisco Veterans Administration Med Ctr

San Francisco, United States

Gary Richmond MD

Fort Lauderdale, United States

Northstar Med Clinic

Chicago, United States
Suspended10 Study Centers