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A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Efavirenz
Emtricitabine
Stavudine
Sponsored by
Triangle Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dideoxynucleosides, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, abacavir, efavirenz

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria You may be eligible if you: Are HIV-positive and generally healthy. Have a viral load of 5,000 copies/ml or more. Have CD4 cell counts of 200 cells/mm3 or more. Are age 18 or older. Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms). Exclusion Criteria You will not be eligible if you: Have ever taken anti-HIV drugs for 3 days or more. Have had certain AIDS-related infections. Have had severe diarrhea within the past 30 days. Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain. Are being treated for active tuberculosis (TB). Are pregnant or breast-feeding. Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments. Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).

Sites / Locations

  • Ctr for AIDS Research / Education and Service (CARES)
  • San Francisco Veterans Administration Med Ctr
  • Gary Richmond MD
  • Northstar Med Clinic
  • South Jersey Infectious Diseases Inc
  • North Shore Univ Hosp / Div of Infectious Diseases
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Houston Clinical Research Network
  • Univ of Texas / Med School at Houston
  • Univ of Texas Health Sciences Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Triangle Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002362
Brief Title
A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title
A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2000
Overall Recruitment Status
Suspended
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Triangle Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Dideoxynucleosides, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, abacavir, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Emtricitabine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible if you: Are HIV-positive and generally healthy. Have a viral load of 5,000 copies/ml or more. Have CD4 cell counts of 200 cells/mm3 or more. Are age 18 or older. Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms). Exclusion Criteria You will not be eligible if you: Have ever taken anti-HIV drugs for 3 days or more. Have had certain AIDS-related infections. Have had severe diarrhea within the past 30 days. Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain. Are being treated for active tuberculosis (TB). Are pregnant or breast-feeding. Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments. Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).
Facility Information:
Facility Name
Ctr for AIDS Research / Education and Service (CARES)
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
South Jersey Infectious Diseases Inc
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
North Shore Univ Hosp / Div of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Univ of Texas / Med School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Texas Health Sciences Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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