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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000922
First received: November 2, 1999
Last updated: April 16, 2014
Last verified: April 2014

November 2, 1999
April 16, 2014
Not Provided
January 2003   (final data collection date for primary outcome measure)
  • Change in CD4 count from baseline to the average of all readings obtained at the regular follow-up visits beginning at Month 32
  • 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
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Complete list of historical versions of study NCT00000922 on ClinicalTrials.gov Archive Site
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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)
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Abacavir sulfate
  • Drug: Nelfinavir mesylate
  • Drug: Efavirenz
  • Drug: Nevirapine
  • Drug: Lamivudine
  • Drug: Stavudine
  • Drug: Didanosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1710
June 2006
January 2003   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000922
CPCRA 058, 11611
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Rodger D. MacArthur, MD University Health Center, Wayne State University
Study Chair: Richard Novak, MD University of Illinois at Chicago
National Institute of Allergy and Infectious Diseases (NIAID)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP