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Completed

NCT Number: NCT00053638

A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be able to provide informed consent.
  • Have documented HIV-1 infection.
  • Have not received more than 14 days of prior treatment with antiretroviral drugs.
  • Meet laboratory test criteria.
  • Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
  • Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria

  • Enrolled in other HIV treatment studies.
  • Pregnant or breastfeeding.

Treatment and study plan

Efavirenz

Drug

Tenofovir

Drug

Abacavir/Lamivudine

Drug

Other names: efavirenz, tenofovir

Primary outcomes

  1. Viral load response at 48 weeks

    Time frame: 48 weeks

Secondary outcomes

  1. Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Feb 5, 2003
Registry last updated
Oct 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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