A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine

NCT ID: NCT00001267

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1990-10-31
• Study Completion Date: 2000-04-30

Brief Summary

Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.

Detailed Description

Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.

Conditions

AIDS-Related Complex; Acquired Immunodeficiency Syndrome

Study Design

• Primary Study Purpose: TREATMENT

Interventions

zidovudine

Intervention Type: DRUG

2',3'-dideoxyinosine

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

Hb less than 10.0 gm per dl or transfusion within the last month, or

WBC less than 2000 per mm(3) or

Platelets less than 75,000 per mm(3).

No history of hepatic cirrhosis or present hepatic dysfunction with:

Total bilirubin greater than 3.0 mg per dl (2x the upper limit of normal).

Alkaline phosphatase greater than 372 U per l (3x the upper limit of normal).

AST/GOT greater than 132 U per l (3x the upper limit of normal).

No evidence of severe diarrhea (over 5 stools per day), an underlying severe infection (including CMV retinitis, colitis, or pneumonitis); or evidence of Kaposi's sarcoma or other tumor which is likely to require specific anti-tumor therapy within 24 months of entering the study:

As a practical matter, only patients with Kaposi's sarcoma who have a few cutaneous lesions with no mucosal or internal lesions will be eligible.

Patients will be ineligible if they have some evidence of active life-threatening infections with bacterial, viral, fungal, or protozoan pathogens at the time of entry into the study. In general, patients who have had a fever of 39 degrees Celsius within the past 10 days will in general be ineligible unless it is apparent that this is not the result of a severe underlying infection.

No known hypersensitivity reactions to or major toxicities from AZT or ddI. (This would include anaphylaxis reactions, hives, or Stevens Johnson syndrome, but would not include the minor rash occasionally seen with ddI.)

Patients must be willing to give informed consent, attend the outpatient clinic, and refrain from unprotected sexual contact or other activities which may result in re-infection with HIV. Present use of illicit drugs (for example, heroin or cocaine) or ingestion of substantial alcohol (enough to increase the risk of pancreatitis) will exclude the patient from the study.

No evidence of underlying cardiac disease, history of pancreatitis, or peripheral neuropathy.

No treatment within the last 4 months with suramin, treatment within the last 3 months with ribavirin, or treatment within the past 4 weeks with any anti-retroviral drug, cytotoxic chemotherapeutic agents, steroids, interferon, or immunomodulating agents.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Locations

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Countries

United States

References

Yarchoan R, Broder S. Development of antiretroviral therapy for the acquired immunodeficiency syndrome and related disorders. A progress report. N Engl J Med. 1987 Feb 26;316(9):557-64. doi: 10.1056/NEJM198702263160925.

Reference Type: BACKGROUND

PMID: 3543683 (View on PubMed)

Yarchoan R, Mitsuya H, Thomas RV, Pluda JM, Hartman NR, Perno CF, Marczyk KS, Allain JP, Johns DG, Broder S. In vivo activity against HIV and favorable toxicity profile of 2',3'-dideoxyinosine. Science. 1989 Jul 28;245(4916):412-5. doi: 10.1126/science.2502840.

Reference Type: BACKGROUND

PMID: 2502840 (View on PubMed)

Other Identifiers

91-C-0018

Identifier Type: -

Identifier Source: secondary_id

910018

Identifier Type: -

Identifier Source: org_study_id