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

See Detailed Description

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044577

Enrollment

166

Registered

2002-09-04

Start date

2002-07-16

Completion date

2004-05-25

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus I, HIV Infection

Keywords

HIV-1 Abacavir Lamivudine Tenofovir

Brief summary

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.

Detailed description

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.

Interventions

DRUGabacavir/lamivudine

DRUGabacavir

DRUGlamivudine

DRUGtenofovir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Viral load response T-cell count Health Outcomes Resistance	—

Countries

Belgium, Canada, France, Germany, Italy, Portugal, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026