NCT00116116

Brief Summary

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Mar 2002

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2005

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

3.3 years

First QC Date

June 27, 2005

Last Update Submit

April 14, 2011

Conditions

HIV InfectionsAIDS

Keywords

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

  • Estimate efficacy of d4T-XR/3TC/EFV given QD determined by

  • proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks

Secondary Outcomes (13)

  • Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96

  • Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96

  • Determine viral suppression of plasma HIV RNA change in baseline at week 48

  • Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation

  • Evaluate time to undetectable plasma HIV RNA

  • +8 more secondary outcomes

Interventions

efavirenz, stavudine extended release, lamivudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older infected with HIV and weigh at least 40 kg.
  • Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater.
  • Be willing to use two forms of contraception throughout study.
  • No previous exposure to antiretroviral (ARV) drugs

You may not qualify if:

  • Pregnancy or breastfeeding
  • Physical or psychiatric disability
  • Proven or suspected acute hepatitis within 30 days prior to study entry
  • Active AIDS-defining opportunistic infection or disease
  • History of acute or chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Local Institution

Bakersfield, California, United States

Location

Local Institution

San Francisco, California, United States

Location

Local Institution

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

Location

Local Institution

Fort Lauderdale, Florida, United States

Location

Local Institution

Jacksonville, Florida, United States

Location

Local Institution

Miami, Florida, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Greenville, North Carolina, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Dallas, Texas, United States

Location

Related Publications (2)

  • Jayaweera D, Dejesus E, Nguyen KL, Grimm K, Butcher D, Seekins DW. Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naive HIV-1-infected patients over 96 weeks. HIV Clin Trials. 2009 Nov-Dec;10(6):375-84. doi: 10.1310/hct1006-375.

    PMID: 20133268BACKGROUND

  • Nunes EP, Santini de Oliveira M, Mercon M, Zajdenverg R, Faulhaber JC, Pilotto JH, Ribeiro JE, Norton M, Schechter M. Monotherapy with Lopinavir/Ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clin Trials. 2009 Nov-Dec;10(6):368-74. doi: 10.1310/hct1006-368.

    PMID: 20133267DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

efavirenzLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2005

First Posted

June 28, 2005

Study Start

March 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

US(10)