Safety of the maternal–infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study

AIDS ◽  
1998 ◽  
Vol 12 (14) ◽  
pp. 1805-1813 ◽  
Author(s):  
Rhoda S. Sperling ◽  
David E. Shapiro ◽  
George D. McSherry ◽  
Paula Britto ◽  
Bethann E. Cunningham ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Trial Group ◽  
Pediatric Aids ◽  
Aids Clinical Trial Group ◽  
Zidovudine Regimen

scholarly journals Role of oral candidiasis in TB and HIV co-infection: AIDS Clinical Trial Group Protocol A5253

2014 ◽  
Vol 18 (6) ◽  
pp. 682-688 ◽  
Author(s):  
C. H. Shiboski ◽  
H. Chen ◽  
M. A. Ghannoum ◽  
L. Komarow ◽  
S. Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oral Candidiasis ◽  
Trial Group ◽  
Aids Clinical Trial Group

Predictors of Antiretroviral-Related Hepatotoxicity in the Adult AIDS Clinical Trial Group (1989-1999)

2006 ◽  
Vol 43 (3) ◽  
pp. 320-323 ◽  
Author(s):  
Julie C Servoss ◽  
Douglas W Kitch ◽  
Janet W Andersen ◽  
Ronald B Reisler ◽  
Raymond T Chung ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Trial Group ◽  
Aids Clinical Trial Group

scholarly journals Population Pharmacokinetics and Pharmacodynamics of Efavirenz, Nelfinavir, and Indinavir: Adult AIDS Clinical Trial Group Study 398

2003 ◽  
Vol 47 (1) ◽  
pp. 130-137 ◽  
Author(s):  
Marc Pfister ◽  
Line Labbé ◽  
Scott M. Hammer ◽  
John Mellors ◽  
Kara K. Bennett ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Virological Failure ◽  
Hepatic Clearance ◽  
Population Pharmacokinetic ◽  
Trial Group ◽  
Event Monitoring ◽  
Nonnucleoside Reverse Transcriptase Inhibitors ◽  
Aids Clinical Trial Group ◽  
Percent Increase ◽  
The Relationship

ABSTRACT The present population pharmacokinetic (PK) and pharmacodynamic (PD) study modeled the effects of covariates including drug adherence and the coadministration of protease inhibitors (PIs) on the pharmacokinetics of efavirenz (EFV) and the relationship between EFV exposure and virological failure in patients who failed initial PI treatment in Adult AIDS Clinical Trial Group (AACTG) study 398. We also report on the population PKs of the PIs nelfinavir (NFV) and indinavir (IDV). AACTG study 398 patients received EFV, amprenavir, adefovir dipivoxil, and abacavir and were randomized to take, in addition, one of the following: NFV, IDV, saquinavir (SQV), or placebo. The PK databases consisted of 531 EFV concentrations (139 patients), 219 NFV concentrations (75 patients), and 66 IDV concentrations (11 patients). Time to virological failure was ascertained for all patients in the PK databases. PK data were fit with a population PK model that assumed exclusive hepatic elimination (the well-stirred model). Notable findings with respect to EFV PK and PD are as follows. (i) The hepatic clearance of EFV is unaltered by NFV, IDV, or SQV coadministration. (ii) The hepatic clearance of EFV appears to be 28% higher in white non-Hispanics than in African Americans and Hispanics (P = 0.03). (iii) Higher adherence scores (as measured with the Medication Event Monitoring System) are associated with marginally increased levels of exposure to EFV. (iv) In patients with no prior experience with nonnucleoside reverse transcriptase inhibitors (NNRTIs), a given percent increase in the oral clearance (CL/F) of EFV is associated with a greater percent increase in the hazard of virological failure (P < 0.0003). Among NNRTI-experienced patients, however, hazard is relatively uncorrelated with EFV CL/F.

Fumagillin analog in the treatment of Kaposi's sarcoma: a phase I AIDS Clinical Trial Group study. AIDS Clinical Trial Group No. 215 Team.

1998 ◽  
Vol 16 (4) ◽  
pp. 1444-1449 ◽  
Author(s):  
B J Dezube ◽  
J H Von Roenn ◽  
J Holden-Wiltse ◽  
T W Cheung ◽  
S C Remick ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Partial Response ◽  
Kaposi's Sarcoma ◽  
Single Agent ◽  
Angiogenesis Inhibitor ◽  
Kaposi’S Sarcoma ◽  
Trial Group ◽  
Cutaneous Lesions ◽  
Aids Clinical Trial Group ◽  
Dose Levels

PURPOSE Angiogenesis is a major component of Kaposi's sarcoma (KS) and a critical process in tumor growth. The present study was designed primarily to test the toxicity and pharmacokinetics (PK) of the angiogenesis inhibitor TNP-470 and secondarily to evaluate tumor response in patients with early AIDS-related KS. PATIENTS AND METHODS Patients with AIDS-related KS were required to have cutaneous disease with > or = 5 measurable lesions and no evidence of pulmonary, symptomatic gastrointestinal, or acutely life-threatening KS. Thirty-eight patients received TNP-470 by weekly intravenous infusion over 1 hour at one of six dose levels for up to 24 weeks. RESULTS The dose levels tested included 10, 20, 30, 40, 50 and 70 mg/m2. Median CD4 count was 24 cells/microl (range, 0 to 460). Fourteen patients (36%) had > or = 50 cutaneous lesions and 19 (49%) had oral lesions. Adverse events included neutropenia (n = 2), hemorrhage (n = 3), and urticaria (n = 1). PK studies showed wide interpatient and intrapatient variability. Elimination half-life values were short (range, 0.01 to 0.61 hours). Seven patients (18%) achieved a partial response. The median time to partial response was 4 weeks (range, 2 to 25), and the median duration of response was 11 weeks (range, 3 to 26+). CONCLUSION TNP-470, administered as a weekly, 1-hour infusion to patients with early AIDS-KS is well-tolerated at doses up to and including the highest dose tested. Tumor responses were observed in a substantial number of cases and occurred at various dose levels. TNP-470 should be evaluated further in patients with AIDS-KS as a single agent and in combination with other biologic response modifiers in early disease or after initial response to cytotoxic chemotherapy.

AIDS Clinical Trial Group-Revised, 9-Item Version

2006 ◽  
Author(s):  
William L. Holzemer ◽  
Suzanne Bakken ◽  
Carmen J. Portillo ◽  
Richard Grimes ◽  
Jennifer Welch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Trial Group ◽  
Aids Clinical Trial Group
Sign in / Sign up

Export Citation Format

Share Document