Completed

Evaluation of Safety and Tolerability of Antiretroviral Therapy in HIV-1 Infected Subjects

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

Lamivudine/Zidovudine

+ Abacavir sulfate

+ Nelfinavir mesylate

Drug
Who is being recruted

Blood-Borne Infections+18

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 1999
See protocol details

Summary

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

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

NCT00005106
Principal SponsorGlaxo Wellcome
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

230 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 DiseasesInfectionsMetabolic DiseasesNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, MetabolicVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin and Connective Tissue DiseasesLipid Metabolism DisordersLipodystrophyHIV Infections

Criteria

6 inclusion criteria required to participate
Are HIV-positive
Are at least 18 years old
Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study
Have a CD4 count greater than 50 cells/mm3
Show More Criteria
10 exclusion criteria prevent from participating
Are enrolled in another study
Are pregnant or breast-feeding
Are taking certain medications
Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule
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 39 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Arizona Clinical Research Ctr Inc

Tucson, United States

Longbeach Memorial Med Ctr

Longbeach, United States

Good Samaritan Hosp

Los Angeles, United States
Completed39 Study Centers