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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Emtricitabine (Drug); Lamivudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Triangle Pharmaceuticals

Official(s) and/or principal investigator(s):
Charles van der Horst, Study Chair

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.

Clinical Details

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 design: Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dr Robert Wallace, St. Petersburg, Florida 33713, United States

North Shore Univ Hosp, Great Neck, New York 11021, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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