T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00008528
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.

Detailed Description

Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed in this study for a maximum of 100 weeks from their initial baseline visit date.

Study Timeline

• Study First Submitted: 2001-01-12
• Status Verified: 2001-06
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (37)

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Phoenix Body Positive; 🇺🇸 Phoenix, Arizona, United States

Pacific Oaks Med Group; 🇺🇸 Beverly Hills, California, United States

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States

Univ of California, San Diego; 🇺🇸 San Diego, California, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

San Francisco VA Med Ctr; 🇺🇸 San Francisco, California, United States

Univ of Colorado Health Sciences Ctr; 🇺🇸 Denver, Colorado, United States

Whitman Walker Clinic/Elizabeth Taylor Med Ctr; 🇺🇸 Washington, District of Columbia, United States

IDC Research Initiative; 🇺🇸 Altamonte Springs, Florida, United States

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