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Completed Phase 2 Interventional

A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients

ClinicalTrials.gov ID: NCT00001084

Public ClinicalTrials.gov record NCT00001084. 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 27, 2026, 5:49 AM EDT

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

Official title

A Prospective Randomized Double-Blind Trial of Three Maintenance Regimens for HIV-Infected Subjects Receiving Induction Therapy With Zidovudine, Lamivudine and Indinavir

Brief summary

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

To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels \[AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay\] among the 3 regimens during the maintenance phase. The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.

Study identification

NCT ID
NCT00001084
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
500 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 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
Nov 30, 1997
Last update posted
Nov 3, 2021

Ends 1997

United States locations

U.S. sites
45
U.S. states
20
U.S. cities
31
Facility City State ZIP Site status
Univ of Southern California / LA County USC Med Ctr Los Angeles California 900331079 —
Univ of California / San Diego Treatment Ctr San Diego California 921036325 —
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 —
Harbor UCLA Med Ctr Torrance California 90502 —
Univ of Colorado Health Sciences Ctr Denver Colorado 80262 —
Univ of Miami School of Medicine Miami Florida 331361013 —
Emory Univ Atlanta Georgia 30308 —
Queens Med Ctr Honolulu Hawaii 96816 —
Univ of Hawaii Honolulu Hawaii 96816 —
Northwestern Univ Med School Chicago Illinois 60611 —
Cook County Hosp Chicago Illinois 60612 —
Indiana Univ Hosp Indianapolis Indiana 462025250 —
Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana 46202 —
Univ of Iowa Hosp and Clinic Iowa City Iowa 52242 —
Tulane Med Ctr Hosp New Orleans Louisiana 70112 —
Tulane Univ School of Medicine New Orleans Louisiana 70112 —
State of MD Div of Corrections / Johns Hopkins Univ Hosp Baltimore Maryland 212052196 —
Johns Hopkins Hosp Baltimore Maryland 21287 —
Harvard (Massachusetts Gen Hosp) Boston Massachusetts 02114 —
Beth Israel Deaconess - West Campus Boston Massachusetts 02215 —
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 —
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 —
Mem Sloan - Kettering Cancer Ctr New York New York 10021 —
Mount Sinai Med Ctr New York New York 10029 —
Univ of Rochester Medical Center Rochester New York 14642 —
Univ of North Carolina Chapel Hill North Carolina 275997215 —
Carolinas Med Ctr Charlotte North Carolina 28203 —
Moses H Cone Memorial Hosp Greensboro North Carolina 27401 —
Univ of Cincinnati Cincinnati Ohio 452670405 —
Case Western Reserve Univ Cleveland Ohio 44106 —
MetroHealth Med Ctr Cleveland Ohio 441091998 —
Ohio State Univ Hosp Clinic Columbus Ohio 432101228 —
Julio Arroyo West Columbia South Carolina 29169 —
Univ of Texas Galveston Galveston Texas 775550435 —
Univ of Washington Seattle Washington 981224304 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00001084, 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 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00001084 live on ClinicalTrials.gov.

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