National Toxicology Program

Infection with human immunodeficiency virus (HIV) causes immunosuppression and leads to acquired immunodeficiency syndrome (AIDS) with a broad spectrum of opportunistic infections. Prophylaxis and treatment of AIDS are generally combination therapies of antiretroviral agents with antimicrobial drugs specific for the opportunistic infections. The National Institute of Environmental Health Sciences (NIEHS), under the AIDS research program, collaborates with other institutes of the NIH, other government agencies, and pharmaceutical companies to evaluate the reproductive/developmental toxicity, general toxicity, immunotoxicity and neurotoxicity of AIDS therapeutics. These evaluations may include single therapeutic agents or combination therapies when the toxic potential of these agents in animal models is not available or is incomplete. The studies with combination therapies are very important in that they will increase awareness and understanding of interactions between antiretroviral therapies and other drugs/substances that HIV-infected individuals may be using.

NIEHS AIDS Therapeutics Toxicity Reports:

• AIDS Toxicity Report Number 1: NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of Pyrazinamide (CAS No. 98-96-4) Administered by Gavage to Swiss CD-1®) Mice

• AIDS Toxicity Report Number 2: NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of 3'-Azido-3'-dioxythymidine (AZT), Trimethoprim (TMP)/ Sulfamethoxazole (SMX), and Folinic Acid Combinations Administered by Gavage to Swiss CD-1®) Mice

• AIDS Toxicity Report Number 3: NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of 3'-Azido-3'-dioxythymidine (AZT) and Isoniazid Combinations (CAS Nos. 30516-87-1 and 54-85-3) Administered by Gavage to Swiss CD-1®) Mice

• AIDS Toxicity Report Number 4: NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Study of 3'-Azido-3'-deoxythymidine (AZT) and Rifabutin Combinations (CAS Nos. 30516-87-1 and 72559-06-9) Administered by Gavage to Swiss (CD-1®) Mice (pdf document)

• AIDS Toxicity Report Number 5: NIEHS Technical Report on the Subchronic Toxicity Study of 3'-Azido-3'-dioxythymidine (AZT) and Pyrazinamide Combinations (CAS Nos. 30516-87-1 and 98-96-4) Administered by Gavage to B6C3F₁ Mice (pdf document)

•  AIDS Toxicity Report Number 6: NIEHS Technical Report on the Subchronic Toxicity Study of 3'-Azido-3'-dioxythymidine (AZT) and Rifampin Combinations (CAS Nos. 30516-87-1 and 13292-46-1) Administered by Gavage to B6C3F₁ Mice (pdf document)

• AIDS Toxicity Report Number 7: NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Study of 3'-Azido-3'-deoxythymidine (AZT) and Pyrazinamide Combinations (CAS Nos. 30516-87-1 and 98-96-4) Administered by Gavage to Swiss CD-1® Mice (pdf document)

• AIDS Toxicity Report Number 8: NIEHS Technical Report on the 13-Week Toxicity Study of 3'-Azido-3'-deoxythymidine (AZT) and Isoniazid Combinations (CAS Nos. 30516-87-1 and 54-85-3) Administered by Gavage to B6C3F₁ Mice (pdf document)

• AIDS Toxicity Report Number 9: NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of 3'-Azido-3'-deoxythymidine (AZT) and Clarithromycin Combinations (CAS Nos. 30516-87-1 and 81103-11-9) Administered by Gavage to Swiss CD-1® Mice (pdf document)

AIDS Publication Abstracts:

• Sanders VM, Elwell MR, Heath JE, Collins BJ, Dunnick JK, Rao GN, Prejean D, Lindamood C III, Irwin RD. Induction of Thymic Lymphoma in Mice Administered the Dideoxynucleoside ddC. Fundamental and Applied Toxicology; 27 (2). 1995. 263-269.

• Rao GN, Collins BJ, Giles HD, Heath JE, Foley JF, May RD, Buckley LA. Carcinogenicity of 2',3'-Dideoxycytidine in Mice. Cancer Res; VOL 56, ISS 20, 1996, P4666-72.

• Ghanta N. Rao, Charles Lindamood III, James E. Heath, Daniel R. Farnell, and Hirschell D.Giles. Subchronic Toxicity of Human Immunodeficiency Virus and Tuberculosis Combination Therapies in B6C3F₁ Mice. Toxicological Sciences; 45, 113-127 (1998).

To receive printed copies of these documents or publications, contact Central Data Management

Links to other AIDS Information Sites

• National Institute of Allergy and Infectious Diseases - Division of Acquired Immune Deficiency Syndrome

• The National Library of Medicine - AIDS Information Resources

• Report of the NIH AIDS Research Program Evaluation Working Group -- Office of AIDS Research Advisory Council

• CDC National Prevention Information Network

• Department of Veterans Affairs -- AIDS Research Center

• The Joint United Nations Program on HIV/AIDS

• AIDS Hotlines and Service Organizations