National Institutes of Allergy and Infectious Diseases (NIAID)
Purpose Of The Database And Study Design: The AACTG, the largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the US and the developed world. The AACTG has been pivotal in providing the data necessary for the approval of therapeutic agents, as well as the treatment and prevention strategies, for many OIs and malignancies. The AACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research.
Nature Of The Data Collected: Baseline and followup data collected for efficacy evaluations of HIV therapies within large-scale, multi-site clinical trials. Endpoints may include clinical outcomes, CD4 cell counts, or HIV RNA load.
Unit Of Analysis: HIV positive adults
General Attributes: Studies typically include several hundred subjects in each treatment arm.
Major Data Constructs And Key Data Elements: Through innovative hypothesis-based and pathogenesis-oriented studies of the treatment of HIV-1 infection and its sequelae, AACTG research focuses on:
- Therapeutic interventions based on knowledge of disease pathogenesis;
- Treatment strategies to limit replication of HIV-1 and improve disease-free survival among infected individuals;
- Rapid development of agents that prevent or delay the complications of HIV-related disorders;
- HIV-1 pathogenesis through advanced laboratory investigation;
- Recruitment and retention of clinical trial participants who reflect the changing demographics of the AIDS epidemic;
- Therapeutic approaches that improve quality of life for persons with HIV-1 infection.
Strengths And Weaknesses Of The Study Design And Database: Not available.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified.
Feasibility Of Linking With Other Databases: Study subject names are strictly confidential and no identifying information is available.
For more information see the AACTG web site at: aactg.s-3.com. The following NIAID AACTG data sets have been submitted to NTIS for public use:
The Efficacy & Safety of a Lower Dose of Zidovudine in the Treatment of Patients with AIDS-Associated Pneumocystis Carinii Pneumonia: A Randomized Controlled Trial. NTIS PB 93506087
Safety and Efficacy of Zidovudine for Asymptomatic HIV Infected Individuals (CD4+cell counts above 500/mm3). NTIS PB 96502661
Safety and Efficacy of Zidovudine for Asymptomatic HIV Infected Individuals (CD4+cell counts below 500/mm3). NTIS PB 94501871 (diskette and protocol)
Trimethoprim-Sulfamethazole Versus Aerosolized Pentamidine For Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Zidovudine: AIDS Clinical Trial Group Protocol NTIS PB95500229 (diskette and protocol) NTIS PB 500574 (protocol only)
A Double-Blind, Placebo Controlled Trial to Evaluate Intravenous Gamma Globulin in Children with Symptomatic HIV Infection Receiving Zidovudine NTIS PB-97501258 (diskette and protocol), NTIS PB97-116867 (protocol only)
Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Zidovudine for the Prevention of Maternal-Fetal HIV Transmission NTIS Accession number pending, Submitted September 1997
A Randomized Trial of Three Anti-Pneumocystis Agents plus ZDV for the Primary Prevention of Serious Infections in Patients with Advanced HIV Infection. NTIS PB 96-502141
Zidovudine Compared with Didanosine in Patients With Advanced HIV Type 1 Infection and Little or No Previous Experience With Zidovudine NTIS PB 97-503171
Controlled Trial Comparing Continued ZDV with ddI in Human Immunodeficiency NTIS PB94-504099GEI
Randomized, Double Blind Comparative Study of Dideoxycytidine (ddC) Alone or ddC/ZDV Combination Versus Zidovudine (ZDV) Alone in Patients with HIV Infections Who Have Received Prior ZDV Therapy. NTIS PB96502695 (diskette and protocol) NTIS PB96184056 (protocol only)
A Randomized, Double-Blind Comparative Study of dideoxycytidine (ddC) Alone or ddC/ZDV Combination versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy. NTIS PB 98172539 (protocol only) and PB 99500159 (diskette)
Randomized, Double-Blind, Phase III Study of Indinavir Sulfate (IDV) with Open-Label ZDV or Stavudine (d4T) and Lamivudine (3TC) in Subjects with HIV Infection with CD4 Cell Counts < 200 cells/mm3 and > 3 Months of Zidovudine Experience. NTIS PB 98502560 (diskette)
Bakshi S. Evaluation of pharmacokinetics, safety, tolerance, and activity of combination zalcitabine and zidovudine (ZDV) in stable, ZDV-treated, pediatric patients with HIV infection. Journal of Infectious Diseases. 175:1039-1050, 1997.
Boucher F. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. Journal of Pediatrics. 122(1): 137-144, 1993.
Brady M. Randomized study of the tolerance and efficacy of high versus low dose zidovudine in HIV positive children with mild to moderate symptoms (ACTG 128). Journal of Infectious Diseases. 173(5): 1097-1106, 1996.
Connor E. Reduction of maternal-infant transmission of human immunodeficiency virus 1 with zidovudine treatment: results of AIDS Clinical Trial Group Protocol 076. NEJM. 331(18): 1173-1180, 1994.
England J. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV positive children. NEJM. 336(24) 1704-1712, 1997.
Kline M. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. Pediatrics. 101(2): 214-220, 1998.
Luzuriaga K. Phamacokinetics, safety, and activity of nevirapine in HIV Type 1 infected children. Journal of Infectious Diseases. 174: 713-721, 1996.
Luzuriaga K. Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus Type 1 infection. NEJM. 336(19): 1343-1349, 1997.
McKinney R. Safety and tolerance to intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Journal of Pediatrics. 116(4): 640-647, 1990.
McKiney R. A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. NEJM. 324(15): 1018-1025, 1991.
O’Sullivan M. The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: Phase I Acquired Immunodeficiency Syndrome Clinical Trials Group Study (Protocol 082).American Journal of Obstetrics and Gynecology. 168(5): 1510-1516, 1993.
Shearer W. Transport of recombinant human CD4-immunoglobulin G across the human placenta: pharmakinetics and safety in six mother-infant pairs in AIDS Clinical Trials Group Protocol 146. Clinical and Diagnostic Laboratory. 2(3) 281-285, 1995.
Spector S. A controlled trial of intravenous gamma globulin for prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. NEJM. 331(18): 1181-1187, 1994.