NCT00000922

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

Completed NA Last updated 16 April 2014

What this trial tests

NA trial testing Indinavir sulfate in HIV Infections in 1,710 participants. Completed in 1 June 2006.

Timeline

Primary endpoint
1 January 2003

1 June 2006

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,710
Primary completion	1 January 2003
Estimated completion	1 June 2006
Sites	17 locations across United States

Drugs / interventions tested

• Indinavir sulfate
• Abacavir sulfate — full drug profile →
• Nelfinavir mesylate
• Efavirenz (EFAVIRENZ) — full drug profile →
• Nevirapine (NEVIRAPINE) — full drug profile →
• Lamivudine (LAMIVUDINE) — full drug profile →
• Stavudine
• Didanosine (DIDANOSINE) — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

13 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Higher levels of CRP, D-dimer, IL-6, and hyaluronic acid before initiation of antiretroviral therapy (ART) are associated with increased risk of AIDS or death.
   Boulware DR, Hullsiek KH, Puronen CE, Rupert A, et al · · 2011 · cited 261× · PMID 21592994 · DOI 10.1093/infdis/jir134
2. A comparison of three highly active antiretroviral treatment strategies consisting of non-nucleoside reverse transcriptase inhibitors, protease inhibitors, or both in the presence of nucleoside reverse transcriptase inhibitors as initial therapy (CPCRA 058 FIRST Study): a long-te
   MacArthur RD, Novak RM, Peng G, Chen L, et al · · 2006 · cited 103× · PMID 17174704 · DOI 10.1016/s0140-6736(06)69861-9
3. Association between ten-eleven methylcytosine dioxygenase 2 genetic variation and viral load in people with HIV.
   Murray DD, Grund B, MacPherson CR, Ekenberg C, et al · · 2023 · cited 1× · PMID 36473831 · DOI 10.1097/qad.0000000000003427
4. CYP2B6 polymorphisms and suicidal behaviour in people living with HIV treated with efavirenz-containing combination antiretroviral therapy: a global case-control study.
   Arenas-Pinto A, Nordwall J, Carey D, Fletcher CV, et al · · 2026 · PMID 42051257 · DOI 10.3389/fphar.2026.1734919