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Completed Phase 2 Interventional

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

ClinicalTrials.gov ID: NCT00000781

Public ClinicalTrials.gov record NCT00000781. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 28, 2026, 4:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.

Study identification

NCT ID
NCT00000781
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
1,292 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
13 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Aug 31, 1996
Last update posted
Nov 3, 2021

Ends 1996

United States locations

U.S. sites
95
U.S. states
25
U.S. cities
53
Facility City State ZIP Site status
Univ of Alabama at Birmingham Birmingham Alabama 35294 —
Children's Hosp of Los Angeles Los Angeles California 90027 —
Univ of Southern California / LA County USC Med Ctr Los Angeles California 900331079 —
Huntington Memorial Hosp / Children's Hosp of Los Angeles Pasadena California 91105 —
Univ of California / San Diego Treatment Ctr San Diego California 921036325 —
San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California 941102859 —
San Francisco Gen Hosp San Francisco California 941102859 —
Stanford at Kaiser / Kaiser Permanente Med Ctr San Francisco California 94115 —
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose California 951282699 —
San Mateo AIDS Program / Stanford Univ Stanford California 943055107 —
Stanford Univ Med Ctr Stanford California 943055107 —
Olive View Med Ctr Sylmar California 91342 —
Harbor UCLA Med Ctr Torrance California 90502 —
Denver Dept of Health and Hosps Denver Colorado 80262 —
Mountain States Reg Hemo Ctr / Univ of Colorado Denver Colorado 80262 —
Rose Med Ctr Denver Colorado 80262 —
Univ of Colorado Health Sciences Ctr Denver Colorado 80262 —
Yale Univ / New Haven New Haven Connecticut 065102483 —
HIV Ctr - District of Columbia Gen Hosp Washington D.C. District of Columbia 200072197 —
Whitman - Walker Clinic / Georgetown Univ Med Ctr Washington D.C. District of Columbia 200072197 —
Georgetown Univ Med Ctr Washington D.C. District of Columbia 20007 —
George Washington Univ / Hershey Med Ctr Washington D.C. District of Columbia 20037 —
Howard Univ Washington D.C. District of Columbia 20059 —
Univ of Miami School of Medicine Miami Florida 331361013 —
Univ of South Florida Tampa Florida 33612 —
Univ of Hawaii Honolulu Hawaii 96816 —
Northwestern Univ Med School Chicago Illinois 60611 —
Cook County Hosp Chicago Illinois 60612 —
Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois 60612 —
Louis A Weiss Memorial Hosp Chicago Illinois 60640 —
Indiana Univ Hosp Indianapolis Indiana 462025250 —
Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana 46202 —
Univ of Louisville / East Tennesee Comprehensive Hem Ctr Louisville Kentucky 40202 —
Harvard (Massachusetts Gen Hosp) Boston Massachusetts 02114 —
Boston Med Ctr Boston Massachusetts 02118 —
Beth Israel Deaconess - West Campus Boston Massachusetts 02215 —
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial Worcester Massachusetts 01605 —
Hennepin County Med Clinic Minneapolis Minnesota 55415 —
Univ of Minnesota Minneapolis Minnesota 55455 —
St Paul Ramsey Med Ctr Saint Paul Minnesota 55101 —
St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri 63112 —
Univ of Nebraska Med Ctr Omaha Nebraska 681985130 —
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts Lebanon New Hampshire 03756 —
Robert Wood Johnson Med School / Hershey Med Ctr New Brunswick New Jersey 08903 —
Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey 071032714 —
Adirondack Med Ctr at Saranac Lake Albany New York 122083479 —
Albany Med College / Division of HIV Medicine A158 Albany New York 122083479 —
Mid - Hudson Care Ctr Albany New York 122083479 —
SUNY / Health Sciences Ctr at Brooklyn Brooklyn New York 112032098 —
SUNY / Erie County Med Ctr at Buffalo Buffalo New York 14215 —
City Hosp Ctr at Elmhurst / Mount Sinai Hosp Elmhurst New York 11373 —
North Shore Univ Hosp Manhasset New York 11030 —
Beth Israel Med Ctr New York New York 10003 —
Bellevue Hosp / New York Univ Med Ctr New York New York 10016 —
Saint Clare's Hosp and Health Ctr New York New York 10019 —
Cornell Univ Med Ctr New York New York 10021 —
Mem Sloan - Kettering Cancer Ctr New York New York 10021 —
Mount Sinai Med Ctr / Hemophilia Treatment Ctr New York New York 10029 —
Mount Sinai Med Ctr New York New York 10029 —
Columbia Presbyterian Med Ctr New York New York 100323784 —
Harlem Hosp Ctr New York New York 10037 —
Univ of Rochester Medical Center Rochester New York 14642 —
SUNY / State Univ of New York Syracuse New York 13210 —
Bronx Municipal Hosp Ctr/Jacobi Med Ctr The Bronx New York 10461 —
Comprehensive Health Care Ctr / Bronx Municipal Hosp The Bronx New York 10461 —
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp The Bronx New York 10461 —
Montefiore Family Health Ctr / Bronx Municipal Hosp The Bronx New York 10461 —
Samaritan Village Inc / Bronx Municipal Hosp The Bronx New York 10461 —
Jack Weiler Hosp / Bronx Municipal Hosp The Bronx New York 10465 —
Montefiore Med Ctr / Bronx Municipal Hosp The Bronx New York 10467 —
Montefiore Med Ctr Adolescent AIDS Program The Bronx New York 10467 —
North Central Bronx Hosp / Bronx Municipal Hosp The Bronx New York 10467 —
Bronx Veterans Administration / Mount Sinai Hosp The Bronx New York 10468 —
Univ of North Carolina Chapel Hill North Carolina 275997215 —
Moses H Cone Memorial Hosp Greensboro North Carolina 27401 —
Univ of Cincinnati Cincinnati Ohio 452670405 —
Univ of Kentucky Lexington Cincinnati Ohio 45267 —
Case Western Reserve Univ Cleveland Ohio 44106 —
MetroHealth Med Ctr Cleveland Ohio 441091998 —
Columbus Children's Hosp Columbus Ohio 432052696 —
Med College of Ohio Toledo Ohio 43699 —
Milton S Hershey Med Ctr Hershey Pennsylvania 170330850 —
Saint Michael's Med Ctr / Milton S Hershey Med Ctr Hershey Pennsylvania 170330850 —
Girard Med Ctr Philadelphia Pennsylvania 191046073 —
Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania 19104 —
Thomas Jefferson Univ Hosp Philadelphia Pennsylvania 191075098 —
Med Univ of South Carolina / UNC Charleston South Carolina 29425 —
Julio Arroyo West Columbia South Carolina 29169 —
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr Knoxville Tennessee 37920 —
Meharry Med College Nashville Tennessee 37203 —
Univ of Texas Galveston Galveston Texas 775550435 —
Univ Texas Health Science Ctr / Univ Texas Med School Houston Texas 77030 —
Univ of Washington Seattle Washington 981224304 —
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp Green Bay Wisconsin 54301 —
Great Lakes Hemophilia Foundation Wauwatosa Wisconsin 532130127 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000781, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2021 · Synced Sep 28, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000781 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →