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Alternation of Antiretroviral Drug Regimens for HIV Infection: A Randomized, Controlled Trial

Javier Martinez-Picado, PhD; Eugènia Negredo, MD, PhD; Lidia Ruiz, PhD; Ayumi Shintani, PhD, MPH; Carmina R. Fumaz, BS; Carlos Zala, MD; Pere Domingo, MD; Josep Vilaró, MD; Josep M. Llibre, MD; Pompeyo Viciana, MD; Kurt Hertogs, PhD; Charles Boucher, MD, PhD; Richard T. D'Aquila, MD; Bonaventura Clotet, MD, PhD, the SWATCH Study Team*
[+] Article and Author Information

From IrsiCaixa Foundation and Lluita contra la SIDA Foundation, Hospital Germans Trias i Pujol, Badalona, Spain; Vanderbilt University School of Medicine, Nashville, Tennessee; Huesped Foundation, Buenos Aires, Argentina; Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hospital de Vic, Vic, Spain; Hospital St. Jaume Calella, Calella, Spain; Hospital Virgen del Rocío, Sevilla, Spain; Tibotec-Virco, Mechelen, Belgium; and Utrecht University, Utrecht, the Netherlands.


Acknowledgments: The authors thank the patient volunteers and the study coordinators (Jose Miranda, RN; Juan C. Martinez, RN; and Silvia Gel, RN).

Grant Support: In part by grants PM98-0064 (Spanish Ministry of Science and Technology) and NIH R01AI29193 (National Institutes of Health). Dr. Martinez-Picado was supported by contract FIS 99/3132 from the Fundacio per a la Recerca Biomedica Germans Trias i Pujol in collaboration with the Spanish Department of Health. Roche, Bristol-Myers Squibb, and GlaxoSmithKline provided industry support in the form of unrestricted grants.

Potential Financial Conflicts of Interest:Employment: K. Hertogs (Virco); Consultancies: C. Boucher (Bristol-Myers Squibb, Roche), R.T. D'Aquila (GlaxoSmithKline); Honoraria: J. Martinez-Picado (Roche), P. Domingo (Bristol-Myers Squibb), C. Boucher (Bristol-Myers Squibb, Roche, GlaxoSmithKline), R.T. D'Aquila (Agouron, Bristol-Myers Squibb, Gilead Sciences); Stock ownership or options (other than mutual funds): J.M. Llibre (Bristol-Myers Squibb); Grants received: P. Viciana (GlaxoSmithKline, Roche, Bristol-Myers Squibb, Boehringer), C. Boucher (Bristol-Myers Squibb, Roche, GlaxoSmithKline), R.T. D'Aquila (Bristol-Myers Squibb); Patents received or pending: K. Hertogs.

Requests for Single Reprints: Javier Martinez-Picado, PhD, IrsiCaixa Foundation, Hospital Germans Trias i Pujol, Carretera de Canyet s/n, 08916 Badalona, Spain; e-mail, javiermp@ns.hugtip.scs.es.

Current Author Addresses: Drs. Martinez-Picado, Ruiz, and Clotet: IrsiCaixa Foundation, Hospital Germans Trias i Pujol, Carretera de Canyet s/n, 08916 Badalona, Spain.

Dr. Negredo and Ms. Fumaz: Lluita contra la SIDA Foundation, Hospital Germans Trias i Pujol, Carretera de Canyet s/n, 08916 Badalona, Spain.

Dr. Shintani: Center for Health Services Research, Division of General Internal Medicine, Vanderbilt University Medical Center, 6007 Medical Center East, Nashville, TN 37232-8300.

Dr. Zala: Huesped Foundation, Angel Peluffo 3932, C1202ABB, Buenos Aires, Argentina.

Dr. Domingo: Hospital Santa Creu i Sant Pau, Av. St. Antoni Maria Claret 167, 08025 Barcelona, Spain.

Dr. Vilaró: Hospital de Vic, Francesc Pla El Vigatà 1, 08500 Vic, Spain.

Dr. Llibre: Hospital St. Jaume Calella, St. Jaume 209, 08370 Calella, Spain.

Dr. Viciana: Hospital Virgen del Rocío, Av. Manuel Siurot s/n, 41013 Sevilla, Spain.

Dr. Hertogs: Tibotec-Virco, Gen de Wittelaan 11 B4, B-2800 Mechelen, Belgium.

Dr. Boucher: Eijkman-Winkler Institute, Department of Virology, University Medical Centre, Heidelberglaan 100, 3584CX Utrecht, the Netherlands.

Dr. D'Aquila: Division of Infectious Diseases, Vanderbilt University Medical Center, A-4102 Medical Center North, Nashville, TN 37232-2582.

Author Contributions: Conception and design: J. Martinez-Picado, L. Ruiz, C. Boucher, R.T. D'Aquila, B. Clotet.

Analysis and interpretation of the data: J. Martinez-Picado, E. Negredo, A. Shintani, C.R. Fumaz, R. T. D'Aquila.

Drafting of the article: J. Martinez-Picado, E. Negredo, A. Shintani, R.T. D'Aquila.

Critical revision of the article for important intellectual content: J. Martinez-Picado, L. Ruiz, A. Shintani, R.T. D'Aquila.

Final approval of the article: J. Martinez-Picado, E. Negredo, L. Ruiz, A. Shintani, C.R. Fumaz, C. Zala, P. Domingo, J. Vilaró, J.M. Llibre, P. Viciana, K. Hertogs, C. Boucher, R.T. D'Aquila, B. Clotet.

Provision of study materials or patients: E. Negredo, C. Zala, P. Domingo, J. Vilaró, J.M. Llibre, P. Viciana, K. Hertogs, B. Clotet.

Statistical expertise: A. Shintani.

Obtaining of funding: B. Clotet.

Administrative, technical, or logistic support: J. Martinez-Picado.

Collection and assembly of data: J. Martinez-Picado, E. Negredo, C.R. Fumaz.


Ann Intern Med. 2003;139(2):81-89. doi:10.7326/0003-4819-139-2-200307150-00007
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One hundred sixty-one treatment-naive HIV-infected patients were enrolled in the study between June 1999 and April 2000. Patients receiving each regimen did not differ significantly in age, sex, AIDS status, plasma viremia, or CD4 and CD8 cell counts (Table 1). Approximately one fourth of the patients enrolled had baseline HIV RNA levels greater than 100 000 copies/mL, and one fourth had CD4 cell counts less than 0.200 × 109 cells/L. The pattern of missing visits did not differ across study groups. Eight patients were excluded from time-to-event analyses because a viral load decrease to less than 400 copies/mL by week 24 was not documented. Of these 8 patients, 2 had been assigned to regimen A, 5 had been assigned to regimen B, and 1 had been assigned to regimen C.

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Figures

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Figure 1.
Kaplan–Meier plots.Top.Bottom.

Time to first plasma HIV-1 RNA level above 400 copies/mL in the standard-of-care group during the first 48 weeks. Time to first plasma HIV-1 RNA level above 400 copies/mL in the alternating therapy group compared with the standard-of-care group during the first 48 weeks.

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Grahic Jump Location
Figure 2.
Proportion of patients with plasma HIV-1 RNA levels less than 400 copies/mL during 48-week follow-up.Top.Bottom.

Regimen A (efavirenz, didanosine, stavudine) versus regimen B (nelfinavir, zidovudine, lamivudine). Alternating therapy group versus the standard-of-care group (regimens A and B combined). Error bars represent 95% CIs.

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Grahic Jump Location
Figure 3.
Change in mean CD4 cell counts (top) and mean CD8 cell counts (bottom) during 48-week follow-up in the alternating therapy group versus the standard-of-care group.9

Error bars represent standard error. To convert CD4 and CD8 cell counts to × 10 cells/L, multiply by 0.001.

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Summary for Patients

Alternating Drug Regimens To Treat HIV Infection

The summary below is from the full report titled “Alternation of Antiretroviral Drug Regimens for HIV Infection. A Randomized, Controlled Trial.” It is in the 15 July 2003 issue of Annals of Internal Medicine (volume 139, pages 81-89). The authors are J. Martinez-Picado, E. Negredo, L. Ruiz, A. Shintani, C.R. Fumaz, C. Zala, P. Domingo, J. Vilaró, J.M. Llibre, P. Viciana, K. Hertogs, C. Boucher, R.T. D'Aquila, B. Clotet, and the SWATCH Study Team.

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