Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)

A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116298

Enrollment

900

Registered

2005-06-29

Start date

2001-01-31

Completion date

2005-01-31

Last updated

2011-04-25

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

Conditions

AIDS, HIV Infections

Keywords

Antivirals, HIV

Brief summary

The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release \[IR\]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

Interventions

DRUGstavudine, efavirenz, lamivudine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Completed d4T studies AI455-096 or AI455-099 * Have demonstrated compliance with the study medication and treatment visits * Provide written informed consent * Agree to use a barrier method of birth control (such as condoms) during the study * Have a negative pregnancy test within 72 hours prior to start of study medication

Exclusion criteria

* Are pregnant or breast-feeding * Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential * Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis * Have certain other conditions or prior treatments that might interfere with study continuation * Need to take certain medications that should not be taken with EFV

Design outcomes

Primary

Measure	Time frame
Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period	—

Secondary

Measure	Time frame
Efficacy: Changes in CD4 cell counts	—

Countries

Argentina, Belgium, Brazil, Canada, France, Israel, Italy, Mexico, Portugal, Puerto Rico, Russia, Singapore, South Africa, Spain, Thailand, United States

Outcome results

None listed

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