Completed

Simplified Dosing Regimen of Preveon, Videx, Sustiva, and Epivir for HIV-1 Treatment

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

Efavirenz

+ Adefovir dipivoxil

+ Lamivudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

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

Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.

NCT00002234
Principal SponsorGilead Sciences
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

25 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 13 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

4 inclusion criteria required to participate
Are HIV-positive
Are at least 13 years old (need consent of parent or guardian if under 18)
Have a CD4+ count of 50 cells/mm3 or more
Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry
11 exclusion criteria prevent from participating
Abuse alcohol or drugs
Are diagnosed with hepatitis within 30 days prior to study entry
Are enrolled in another anti-HIV drug study while participating in this study
Are pregnant or breast-feeding
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 5 locations

Pacific Oaks Med Group

Beverly Hills, United StatesOpen Pacific Oaks Med Group in Google Maps

Univ of Colorado / Health Science Ctr

Denver, United States

AIDS Research Consortium of Atlanta

Atlanta, United States

Brown Univ School of Medicine

Providence, United States
Completed5 Study Centers