Once Daily 3TC, Efavirenz and ddI for HIV Infection

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Poor compliance is thought to be a major cause of treatment failure. The TEddI study is a randomised, multi-centre, open-label study in well-controlled treatment-experienced HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral therapy versus continuation of current anti-retroviral regimen delivered at least twice daily.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 407 Doctors
• Collaborators: Bristol-Myers Squibb; Merck Sharp & Dohme Corp.
• Treatments: Anti-Retroviral Agents; Efavirenz

Criteria

Inclusion Criteria:

• aged 18 years or more with laboratory evidence of HIV-1 infection

• ability to understand and provide written informed consent to participate in the study

• stable on current ART regimen for at least 3 months prior to screening.

• plasma HIV-RNA less than 400 copies/ml at the screening visit.

• women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to week -4 (assessment of study eligibility)

Exclusion Criteria:

• virological failure of a proposed Once daily arm medication

• a serious medical condition which may compromise the subject's safety, including an active AIDS-defining condition within the previous 6 months

• known toxicities to any of the proposed Once daily arm medications

• laboratory abnormalities at screening:

• serum creatinine greater than twice the upper limit of normal (2 x upper limit of normal (ULN))

• AST, ALT or alkaline phosphatase greater than 5 times the ULN

• lactate greater than 2.5 x ULN

• haemoglobin less than 9.5 g/dL

• women who are pregnant or breast-feeding or who, if of child-bearing potential, are not willing to use adequate contraception (including barrier contraception)

• patients who in the investigator's opinion are unlikely to complete the study