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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: AIDS; HIV Infections

Treatments: Drug: stavudine, efavirenz, lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116298

AI455-110

Details and patient eligibility

About

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.

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)