Search / Trial NCT00001084

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of July 23, 2024

Completed

Keywords

Prospective Studies Drug Therapy, Combination Zidovudine Hiv Protease Inhibitors Lamivudine Indinavir Rna, Viral Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

Description

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 a...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Documented HIV infection.
  • A CD4 cell count >= 200 cells/mm3 within 90 days prior to study entry.
  • Plasma HIV RNA >= 1000 copies/ml within 90 days prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following conditions or symptoms are excluded:
  • A malignancy that requires systemic chemotherapy.
  • Concurrent Medication:
  • Excluded:
  • Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).
  • All antiretroviral therapies other than study medications.
  • Rifabutin and rifampin.
  • Investigational drugs and vaccines.
  • Systemic cytotoxic chemotherapy.
  • Interferon, interleukins, GM-CSF and HIV vaccines.
  • Patients with any of the following prior conditions are excluded:
  • Unexplained temperature > 38.5 degrees C for any 7 days within 30 days prior to study entry.
  • Chronic diarrhea as defined as > 3 liquid stools per day persisting for 15 days within 30 days prior to study entry.
  • Proven or suspected acute hepatitis within 30 days prior to study entry, even if AST and ALT are <= 5.0 X ULN (upper limit of normal).
  • A history of >= Grade 2 bilateral peripheral neuropathy within 60 days prior to study entry.
  • A history of intolerance to 300 mg/day of ZDV defined as any toxicity requiring a dose reduction or termination of ZDV.
  • Prior Medication:
  • Excluded:
  • Acute therapy for an infection or other medical illness within 14 days prior to study entry.
  • Any prior therapy with 3TC or experimental drug 1592.
  • More than 2 weeks of lifetime exposure to protease inhibitor therapy; any exposure within 14 days prior to study entry.
  • Interferons, interleukins, GM-CSF or HIV vaccines within 30 days prior to study entry.
  • Any experimental therapy (drugs or vaccines) within 30 days prior to study entry.
  • Rifampin or rifabutin within 14 days prior to study entry.
  • Systemic cytotoxic chemotherapy within 30 days prior to study entry.
  • Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).

Attachments

readout_NCT00001084_2024-07-23.pdf

4.5 MB

NCT00001084_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Cleveland, Ohio, United States

San Francisco, California, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Torrance, California, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Omaha, Nebraska, United States

New York, New York, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Galveston, Texas, United States

Charlotte, North Carolina, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Iowa City, Iowa, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

New Orleans, Louisiana, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0