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OpenTrials
Completed

NCT Number: NCT00044577

New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

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Key information

Conditions

Infection, Human Immunodeficiency Virus I Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection 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, Brussels, Belgium

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About this study

A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).
  • Patients must be naive to tenofovir.
  • HIV-1 RNA level > 1000 copies/ml on at least one occasion within 21 days of study entry.
  • A CD4 cell count > 50 cells/mm3.
  • Specified viral genotypes.

Exclusion criteria

  • Pregnant or breast-feeding women.
  • Has an active diagnosis of AIDS.
  • Additional qualifying criteria to be determined by the physician.

Treatment and study plan

Abacavir/Lamivudine

Drug

Abacavir

Drug

Lamivudine

Drug

Tenofovir

Drug

Other names: lamivudine, abacavir/lamivudine, abacavir

Primary outcomes

  1. HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety

    Time frame: 48 weeks

Secondary outcomes

  1. Viral load response T-cell count Health Outcomes Resistance

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

See Detailed Description

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Sep 4, 2002
Registry last updated
Mar 24, 2020

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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