Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038506

Enrollment

100

Registered

2002-06-03

Start date

2002-03-31

Completion date

2004-08-31

Last updated

2015-04-08

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

Conditions

HIV Infection

Keywords

HIV-1 TRIZIVIR Tenofovir

Brief summary

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Interventions

DRUGabacavir/lamivudine/zidovudine

DRUGtenofovir

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor). * Plasma HIV - 1 RNA was \<400 copies/ml on at least 2 documented occasions prior to viral rebound. * Have a plasma HIV - 1 RNA value \>400 copies/ml and \<10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks. * A CD4+ lymphocyte count less than or equal to 100.

Exclusion criteria

* Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously. * Have not had an AIDS defining illness within 30 days of screen. * Pregnant or breast-feeding. * Specified viral genotypes upon screening. * And other inclusion or

Design outcomes

Primary

Measure	Time frame
HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.	48 weeks

Secondary

Measure	Time frame
Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes	24 weeks

Countries

United States

Outcome results

None listed

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