Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine

NCT00000732 | Completed

• 2 other identifiers: ACTG 03311009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT reaches the blood, what concentration of AZT is attained in the blood, and how long AZT remains in the blood) changes from day-to-day in the same patient. Also to determine whether the pharmacokinetics of AZT is changed by sulfamethoxazole/trimethoprim (SMX/TMP) given at the same time or whether the pharmacokinetics of SMX/TMP is altered by AZT therapy. AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. It is important to know how drugs interact in patients because addition of a second drug may change the speed at which a drug is eliminated from the body, and cause increased toxic effects or decreased therapeutic effects.

Conditions

HIV Infections

Keywords

Trimethoprim-Sulfamethoxazole Combination; Pneumonia, Pneumocystis carinii; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Sulfamethoxazole-Trimethoprim

Interventions

Sulfamethoxazole-Trimethoprim DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Prior Medication:
• Allowed:
• Zidovudine (AZT) for patients with AIDS.
• AIDS related complex (ARC). The presence of any one of the following findings within 12 months prior to entry and the absence of a concurrent illness or conditions other than HIV infection to explain the findings:
• Fever of \> 38.5 C degrees persisting for longer than 3 weeks.
• Involuntary weight loss of \> 15 lbs. or \> 10 percent of baseline noted in a 120-day period prior to evaluation.
• Diarrhea (\> 2 liquid stools per day) persisting for longer than 1 month.
• History of clinical diagnosis of oral candidiasis or hairy leukoplakia.
• Patients who have AIDS-defining opportunistic infections or tumors.
• Patients eligible for AZT under the labeling.
• A positive HIV antibody test. Exceptions will be made for patients with a previously positive HIV antibody test with progressive disease and patients where virus isolation has been made.
• A life expectancy of at least 3 months.
• Patient with stable Kaposi's sarcoma, mild herpes infection, mild or stable depression, asymptomatic or mild cytomegalovirus or Epstein-Barr virus infection, or a hepatitis B virus carrier state will be acceptable for study.

You may not qualify if:

• Concurrent Medication:
• Excluded:
• Phenytoin.
• Prior Medication:
• Excluded within 30 days of study entry:
• Other antiretroviral agents.
• Patient has any severe ongoing opportunistic infections including Pneumocystis carinii pneumonia (PCP), cryptococcal or toxoplasmosis meningoencephalitis, disseminated herpes simplex or herpes zoster.
• Patient has significant diarrhea at entry ( \> 1 watery stool per day).
• Patient has demonstrated prior sensitivity or has experienced significant adverse effects during prior therapy with the drugs to be used in the study.
• Cannot abstain from alcohol or any other drugs during the study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States

Location

Related Publications (2)

• Berson A, Happy K, Rousseau F, Grateau G, Farinotti R, Sereni D. Effect of zidovudine (AZT) on cotrimoxazole (TMP-SMX) kinetics: preliminary results. Int Conf AIDS. 1993 Jun 6-11;9(1):501 (abstract no PO-B30-2193)

  BACKGROUND

• Canas E, Pachon J, Garcia-Pesquera F, Castillo JR, Viciana P, Cisneros JM, Jimenez-Mejias ME. Absence of effect of trimethoprim-sulfamethoxazole on pharmacokinetics of zidovudine in patients infected with human immunodeficiency virus. Antimicrob Agents Chemother. 1996 Jan;40(1):230-3. doi: 10.1128/AAC.40.1.230.

  PMID: 8787912 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Pneumonia, Pneumocystis; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Thymidine; Pyrimidine Nucleosides; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ptachcinski R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 1990
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)