Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

Back to results

Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Emtricitabine

Lamivudine

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Zalcitabine, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

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

Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have a viral load below 400 copies/ml. Agree to use a barrier method of birth control (such as condoms) during the study. Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.) Exclusion Criteria You will not be eligible for this study if you: Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry. Have had a serious medical event within 30 days prior to study entry. Are taking hydroxyurea. Have Grade 2 or higher peripheral neuropathy. Abuse alcohol or drugs. Are pregnant or breast-feeding.

Sites / Locations

Dr Robert Wallace
North Shore Univ Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002416

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Triangle Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00002416

Brief Title

Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination

Official Title

A Randomized, Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine, Stavudine or Zidovudine, and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor

Study Type

Interventional

2. Study Status

Record Verification Date

March 2000

Overall Recruitment Status

Completed

Study Start Date

undefined (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

The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.

Detailed Description

Patients are randomized to one of two arms in a 2:1 ratio (weighted to Arm 1). Arm 1: Replace lamivudine with FTC while continuing on current background regimen. Arm 2: Continue on current lamivudine-containing regimen. Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy. Stratum 1: Less than 50 copies/ml; PI (protease inhibitor) in treatment regimen. Stratum 2: Less than 50 copies/ml; NNRTI (nonnucleoside reverse transcriptase inhibitor) in treatment regimen. Stratum 3: 50-400 copies/ml; PI in treatment regimen. Stratum 4: 50-400 copies/ml; NNRTI in treatment regimen. Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV-1, Zalcitabine, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

390 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Emtricitabine

Intervention Type

Drug

Intervention Name(s)

Lamivudine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have a viral load below 400 copies/ml. Agree to use a barrier method of birth control (such as condoms) during the study. Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.) Exclusion Criteria You will not be eligible for this study if you: Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry. Have had a serious medical event within 30 days prior to study entry. Are taking hydroxyurea. Have Grade 2 or higher peripheral neuropathy. Abuse alcohol or drugs. Are pregnant or breast-feeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles van der Horst

Official's Role

Study Chair

Facility Information:

Facility Name

Dr Robert Wallace

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

North Shore Univ Hosp

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial