Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.

Completed

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, San Juan, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Documented HIV infection
18 years of age or older and weigh at least 40 kg
Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion criteria

Pregnancy, breastfeeding or plans to become pregnant during the study period
Any prior documented virologic failure to one or more HAART regimens
Active AIDS-defining opportunistic infection or disease
Proven or suspected acute hepatitis within 30 days prior to study entry

Treatment and study plan

stavudine extended-release, lamivudine, efavirenz

Drug

Primary outcomes

Efficacy at week 48

Secondary outcomes

Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Aug 26, 2005
Registry last updated: Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed