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A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

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ClinicalTrials.gov Identifier: NCT00000922
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to determine whether it is better to start an anti-HIV regimen containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment regimen is best as a first treatment for HIV infection.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Didanosine Not Applicable

Detailed Description:

Highly active antiretroviral therapy (HAART) regimens containing PIs, NNRTIs, or nucleoside reverse transcriptase inhibitors (NRTIs) have been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future anti-HIV treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens.

Patients will be randomized to one of three HAART treatment arms:

  • Arm 1 participants will receive one or two PIs plus two NRTIs.
  • Arm 2 participants will receive one NNRTI plus two NRTIs.
  • Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs.

Before randomization to a treatment arm, patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs. The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice. The study-specified NNRTIs will be nevirapine (NVP) or efavirenz (EFV). The study-specified NRTIs will be abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T).

The study sites will provide ABC, 3TC, ddI, or d4T to all patients who are assigned to take these medications. All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription. At Months 1 and 4 and then every 4 months thereafter, patients will receive a medical history update, physical exam, and questionnaire. Blood samples will also be drawn to measure CD4 cell count, viral load, and genotypic antiretroviral resistance. Changes in treatment regimens may occur at any time.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Niave, HIV-Infected Persons
Actual Primary Completion Date : January 2003
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Change in CD4 count from baseline to the average of all readings obtained at the regular follow-up visits beginning at Month 32
  2. time to disease progression, death, or CD4 count less than 200 cells/mm3 at the 4 Month visit for those patients with a baseline CD4 cell count of more than or equal to 200 cells/mm3

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infected
  • Agree to practice abstinence or to use barrier methods of birth control during the study
  • Are at least 13 years old or have signed informed consent from legal guardian for patients between the ages of 13 and 18

Exclusion Criteria:

  • Have ever taken any anti-HIV drugs
  • Are unable to complete the study for any reason
  • Pregnancy
  • Breastfeeding
  • Any condition that, in the investigator's opinion, may interfere with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000922

Show Show 17 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Rodger D. MacArthur, MD University Health Center, Wayne State University
Study Chair: Richard Novak, MD University of Illinois at Chicago
Publications of Results:

Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000922    
Other Study ID Numbers: CPCRA 058
11611 ( Registry Identifier: DAIDS-ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Treatment Naive
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors