A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible

Completed · Phase 2

Conditions studied: HIV Infections

In brief

This study will look at different anti-HIV drug regimens to see which works best to keep the level of HIV (viral load) in the blood as low as possible during maintenance therapy. You will be assigned randomly (like tossing a coin) to 1 of 3 groups: Group 1: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Group 2: Didanosine plus stavudine plus efavirenz (ddI/d4T/EFV). Group 3: This group of patients will remain on their current drug regimens. This study will last approximately 3 years; you will receive study medications for the duration of the study. Anti-HIV drug regimens that include protease inhibitors (PIs) are very good at lowering viral load. However, some patients have a rise in HIV levels while on PI maintenance. It may be possible to keep HIV levels low using another class of drugs for maintenance that are easier to take and less expensive than PIs. If viral load increases while a patient is taking this second group of drugs, it may be possible to restart the PI drug regimen and again decrease HIV levels.

Key facts

Study ID: NCT00000939
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 150
Expected to finish: 2000-01-01
Last updated by the study team: 2021-10-29

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may be eligible for this study if you:
Are at least 13 years old (need consent if under 18).
Are HIV-positive.
Are taking your first anti-HIV drug regimen, which must include a PI and at least one NRTI (nucleoside reverse transcriptase inhibitor) and have been on this regimen for at least 12 months.
Have a viral load less than 400 copies/ml for at least 12 months prior to study entry, and have a viral load less than 50 copies/ml within 60 days of study entry.
Have a CD4 cell count of at least 200 cells/mm3 within 60 days of study entry.
Are willing to go back on the drugs you are currently on, if necessary.
Are willing to use effective methods of birth control during the study and for 3 months after.

You may not qualify if…

You will not be eligible for this study if you:
Have taken ddI, d4T, or HU for more than 2 weeks.
Have taken any NNRTI (non-nucleoside reverse transcriptase inhibitor) for more than 7 days.
Have ever taken EFV.
Have received an HIV vaccine within 30 days prior to study entry.
Have an AIDS-related cancer that requires chemotherapy.
Have or have had pancreatic disease.
Are being treated for a significant illness.
Abuse drugs or alcohol.
Are pregnant or breast-feeding.
Are allergic to any study drugs.
Have received certain medications.

Where it is running

Willow Clinic — Menlo Park, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
Stanford Univ Med Ctr — Stanford, California, United States
Univ of Miami School of Medicine — Miami, Florida, United States
Indiana Univ Hosp — Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
Beth Israel Med Ctr — New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
Chelsea Ctr — New York, New York, United States
Cornell Univ Med Ctr — New York, New York, United States
Univ of Rochester Medical Center — Rochester, New York, United States
Univ of North Carolina — Chapel Hill, North Carolina, United States
Univ of Cincinnati — Cincinnati, Ohio, United States
Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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