Citations 1
Efficacy and Safety of Twice-Daily versus Three-Times Daily Saquinavir Soft Gelatin Capsules as Part of Triple Combination Therapy for HIV-1 Infection
Wheat, L. Joseph , Farthing, Charles, Cohen, Calvin, Pierone, Gerald , Lalezari, Jay , Pilson, Robert S, Siemon-Hryczyk, Peggy, Appendix), for the TIDBID (NR15520/M61018) study team (members listed in, Baxter, John, Beer, Victor L., Bellos, Nicholas, Bissett, Jack, Braun, James, Brosgart, Carol, Burnside, Alfred F., Cervia, Joe, Cheeseman, Sarah H., Cimoch, Paul J., Cohen, Calvin, DeJesus, Edwin, Diaz, Leslie L, Dieterich, Douglas T. , Dobkin, Jay F., Dretler, Robin, El-Sadr, Waafa, Eng, Robert H.K., Feleke, Getachew, Fessel, Jeffrey , Fish, Douglas N. , Galpin, Jeffrey E., Gathe, Joseph, Gilson, Ian, Gold, Marla, Goodgame, Jeffrey, Greenberg, Richard N. , Greiger, Paola, Grossman, Howard, Grossman, Ron, Hanna, Barbara, Hathaway, Bruce, Hoffman-Terry, Margaret, Jacobson, Susan , Jemsek, Joseph G., Jordan, Wilbert, Kaplan, Mark, Kostman, Jay R., Landesman, Sheldon H., Lindquist, Craig, Madhava, Valsa, Marsh, Bryan J., Martin, Dean, Mathur‐Wagh, Usha, McMeeking, Alexander, Miao, Peter, Mogyoros, Miguel, Mustafa, Mahmoud M., Nadler, Jeffrey P., Norris, Dorece, Onbirbak, Brian, Parker, Richard H, Pearce, Daniel, Pierone, Gerald, Poblete, Ronald, Poretz, Donald M., Reyelt, M Christine, Rivera-Vazquez, Carlos, Salvato, Patricia, Sands, Michael, Schwartz, Robert A., Sension, Michael, Skowron, Gail, Slater, Leonard N., Stavola, Joseph, Steinhart, Corklin, Temesgen, Zelalem , Thompson, Melanie , Timpone, Joseph, Vollmer, Kelly, Wada, Suzanne, Wheat, L Joseph, Yangco, Bienvenido G., Carey, Peter, Jablonowski, H, Theisen, Albert, Ocana, Inma, Appendix), for the TIDBID (NR15520/M61018) study team (members listed in, Burman, William J. , Cohen, Calvin, Feinberg, Judith , Goodrich, James , Jacobson, Susan, Kaplan, Mark, Lalezari, Jacob , MacArthur, Rodger D. , Murphy, Robert L. , Mustafa, Mahmoud, Pierone, Gerald, Reyelt, M. Christine, Smith, David C. , Valentine, Fred T. , Ward, Douglas, Wheat, L Joseph, Carey, Peter, Lazzarin, Adriano , Ocana, Inma
Antiviral Therapy | April 14, 2022 | Volume: 7 | Issue: 3 | Pages: 199-209
Objective The objective of this study was to determine whether a triple therapy regimen incorporating twice-daily saquinavir is as effective as a three-times daily regimen. Methods This was an open-label, Phase III, multicentre, 48-week study involving 837 HIV-1-infected patients randomised to one of the following: saquinavir soft gel capsule (SGC) 1200 mg three-times daily, plus two nucleoside reverse transcriptase inhibitors (NRTIs) (arm A); saquinavir SGC 1600 mg twice-daily, plus two NRTIs (arm B); saquinavir SGC 1200 mg twice-daily and nelfinavir 1250 mg twice-daily, plus a single NRTI (arm C). The primary outcome measure was the virological response in arm A versus B and in arm A versus C with respect to the percentage of patients whose plasma HIV-1 RNA levels fell below the level of quantification for the Amplicor assay (<400 copies/ml) at weeks 24 and 48. Results At 48 weeks, the percentage of patients with plasma HIV-1 RNA levels <400 copies/ml was 47.1% (arm A), 45.3% (arm B) and 42.7% (arm C) in the intention-to-treat analysis. The treatment difference between arm B–arm A was -1.8% (95% confidence intervals -10.1, 6.5) and for arm C–arm A was -4.5% (95% confidence intervals -12.7, 3.7) in the intention-to-treat analysis. These differences fell within the maximum allowable difference (±12%) for arm B compared with arm A. At week 24, the percentage of patients with HIV-1 RNA levels <400 copies/ml was 59.6% (arm A), 57.6% (arm B) and 51.3% (arm C). Conclusions A twice-daily triple therapy regimen incorporating saquinavir SGC plus two NRTIs was of equivalent efficacy to the three-times daily regimen studied. All regimens were generally well tolerated.