A Randomized Factorial Trial Comparing 4 Treatment Regimens in Treatment-Naive HIV-Infected Persons with AIDS and/or a CD4 Cell Count <200 Cells/µL in South Africa

April 23, 2011 at 3:46 pm Leave a comment

Journal of Infectious Diseases 15 Nov  2010  V.202  N.10 P.1529-1537

The Phidisa II Writing Team for Project Phidisaa

Reprints or correspondence: Dr Michael A. Polis, NIAID/NIH, 6700B Rockledge Dr, Room 1118, Bethesda, MD 20892 (mpolis@niaid.nih.gov).

Abstract

Background

Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings.

Methods

In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count <200 cells/µL or a prior AIDS diagnosis were randomized to receive efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC) in an open-label, 2-by-2 factorial study and followed up for the primary outcome of AIDS or death and prespecified secondary outcomes, including CD4 cell count and viral load changes, treatment discontinuation, and grade 4 events.

Results

In total, 1771 persons were randomized and followed up for a median of 24.7 months. AIDS or death occurred in (1) 163 participants assigned EFV and 157 assigned LPV/r (hazard ratio [HR], 1.04 [95% confidence interval {CI}, 0.84–1.30]) and in (2) 170 participants assigned ZDV+ddI and 150 assigned d4T+3TC (HR, 1.15 [95% CI, 0.93–1.44]). HIV RNA levels were lower (P < .001) and CD4 cell counts were greater (P < .01) over follow-up for d4T+3TC versus ZDV+ddI. Rates of potentially life-threatening adverse events and overall treatment discontinuation were similar for d4T+3TC and ZDV+ddI; however, more participants discontinued d4T because of toxicity (12.6%) than other treatments (<5%).

Conclusion

EFV and LPV/r are effective components of first-line ART. The poorer viral and immune responses with ZDV+ddI and the greater toxicity-associated discontinuation rate with d4T+3TC suggest that these treatments be used cautiously as initial therapy.

Trial registration. ClinicalTrials.gov identifier: NCT00342355.

abstract

http://jid.oxfordjournals.org/content/202/10/1529.abstract

Entry filed under: Antirretrovirales, HIV/SIDA, HIV/SIDA HAART, HIV/SIDA Laboratorio.

Antiretroviral Adherence and Development of Drug Resistance Are the Strongest Predictors of Genital HIV-1 Shedding among Women Initiating Treatment Comparative ceftaroline activity tested against pathogens associated with community-acquired pneumonia: results from an international surveillance study

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

Trackback this post  |  Subscribe to the comments via RSS Feed


Calendar

April 2011
M T W T F S S
 123
45678910
11121314151617
18192021222324
252627282930  

Most Recent Posts


%d bloggers like this: