Among the 2,587 patients enrolled in the APPROVe study, mortality data for the period beginning on day 15 after discontinuation of study therapy were available for 2,448.
3) MRL learned of thrombotic events in 2 patients in the study subsequent to finalization of the APPROVe clinical study report on 15-Mar-2005.
The FDA approves new formulation of saquinavir (Fortovase, a soft-gel formulation designed to improve absorption in the body).
The FDA approves Combivir, a combination of zidovudine (Retrovir, AZT) and lamivudine (Epivir, 3TC).
The FDA approves a supplement to the Amplicor HIV-1 Monitor Test, extending the lower limit of viral load quantification from 400 to 50 copies/mL.
The FDA approves Kaletra, a combination pill containing 2 PIs, lopinavir and ritonavir (Norvir), where a small dose of ritonavir is included to boost levels of lopinavir.
The FDA approves Glaxo Wellcome's application to market Trizivir.
The FDA approves a film-coated nelfinavir (Viracept) tablet (for ease of administration).
The FDA approves Bristol-Myers Squibb's enteric-coated didanosine (Videx EC) capsules.
The FDA approves the first genetic test designed to look at virus mutations in an HIV-infected person.
The FDA approves Zerit XR, a new once-daily version of Zerit (stavudine), which never comes to market.
The FDA approves OraQuick Rapid HIV-1 Antibody Test, the first rapid test to use a finger prick.
The FDA approves a new 600-mg version of efavirenz (Sustiva) to reduce pill burden.
The FDA approves the first entry inhibitor enfuvirtide Fuzeon, T20).
The FDA approves Truvada, a fixed-dose, once-daily, co-formulation of the NRTIs emtricitabine (Emtriva, FTC) and tenofovir (Viread).