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HIV InfectionsPhase 1NCT00000656

A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease

A Phase 1 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Didanosine
How many people
116 participants
Where
5 sitesUnited States
Study dates
Start not givento Nov 1993
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine.
  • Acute and intermittent therapy with mycostatin and mycelex.
  • Isoniazid, if no alternative therapy is available.
  • Allowed for up to 2 weeks:
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  • Acyclovir for Herpes infection (withhold didanosine during therapy).
  • Acute therapy with fluconazole or ketoconazole.
  • Allowed but preferably not on a continuous basis for > 72 hours:
  • Acetaminophen.
  • Ibuprofen.
  • Nonsteroidal antiinflammatory agents.
  • Patients must be:
  • HIV antibody positive.
  • Asymptomatic or have persistent generalized lymphadenopathy.
  • Diagnosed with one of the listed coagulopathies.
  • OR Sexual partner of someone with the above criteria.
  • Allowed:
  • Basal cell carcinoma or in situ carcinoma of the cervix.
  • NOTE:
  • As of January, 1991 full accrual of patients with prior AZT use has been reached - NOW ACCRUING ONLY THOSE WITH NO PRIOR AZT USE. Hemophilia restriction has been lifted.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT) for a total of = or < 13 months.
  • NOTE:
  • As of January, 1991 accrual of these patients was reached, NOW ONLY PATIENTS WITH NO PRIOR AZT.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Unexplained temperature > 38 degrees C for more than 5 consecutive days or on more than 10 days in any 30-day period in the 2 years prior to study entry.
  • Unexplained diarrhea defined as at least 3 liquid stools/day persisting more than 7 days within 2 years prior to study entry.
  • Unintentional weight loss of > 10 pounds or > 10 percent of usual body weight within 2 years prior to study entry.
  • Oral hairy leukoplakia at any time prior to study entry.
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  • Recurrent oral candidiasis unrelated to the use of antibiotics within 2 years prior to entry or unrelated to the use of antibiotics within the past 3 months.
  • Herpes zoster within 2 years prior to study entry.
  • Seizures within the past 6 months or currently requiring anticonvulsants for control.
  • Current heart disease.
  • Current psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy.
  • Gout.
  • Concurrent Medication:
  • Excluded:
  • Rifampin.
  • Chemoprophylaxis for Pneumocystis carinii pneumonia other than aerosolized pentamidine.
  • Intravenous pentamidine.
  • Other antiretroviral agents, experimental medication, biological response modifiers, systemic corticosteroids, cimetidine, and ranitidine.
  • Barbiturates.
  • Oral acidifying agents.
  • Patients with a history of any of the following are excluded:
  • AIDS-defining opportunistic infection, advanced AIDS-related complex, or malignancy.
  • Acute or chronic pancreatitis.
  • Grade 2 or higher neuropathy based on the Neuropathy Targeted Symptom Questionnaire.
  • Seizures.
  • Zidovudine therapy for = or > 13 months.
  • Heart disease.
  • Psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy.
  • Gout.
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Antiretroviral agents, including ribavirin, HPA-23, rifampin, AL721.
  • Excluded within 3 months of study entry:
  • Significant course of immunomodulating agents, such as steroids (> 1 week), isoprinosine, thymic factors, or any other experimental drugs.
  • Excluded within 30 days prior to study entry:
  • Neurotoxic drugs.
  • Excluded:
  • Didanosine (ddI).
  • Dideoxycytidine (ddC).
  • Zidovudine (AZT) if received for > 13 months.
  • Prior Treatment:
  • Excluded within 3 months of entry:
  • Other experimental therapy.
  • History of recent alcohol abuse.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Palo Alto Veterans Adm Med Ctr / Stanford Univ

    Palo Alto, California, 94304

  • Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Univ of Pittsburgh Med School

    Pittsburgh, Pennsylvania

  • Univ of Washington

    Seattle, Washington, 981224304

  • Whitman - Walker Clinic

    Washington D.C., District of Columbia, 20009

Other trials in United States

About this study

To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness.

Read the detailed description

Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness.

Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease. After the initial 8 weeks this restriction is lifted. Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone.

Conditions
HIV Infections
Being tested
Zidovudine, Didanosine
Keywords
Didanosine, Drug Therapy, Combination, Zidovudine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionNov 1993

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
116 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000656
Sponsor's protocol ID
ACTG 143
Other IDs
11118
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • Ragni MV, Amato DA, LoFaro ML, DeGruttola V, Van Der Horst C, Eyster ME, Kessler CM, Gjerset GF, Ho M, Parenti DM, et al. Randomized study of didanosine monotherapy and combination therapy with zidovudine in hemophilic and nonhemophilic subjects with asymptomatic human immunodeficiency virus-1 infection. AIDS Clinical Trial Groups. Blood. 1995 May 1;85(9):2337-46.

    PubMed 7727768

  • Mamtora G, Winters M, Drenkow J, Shafer R, Shen N, Tran H, Merigan T, Gingeras T. HIV-1 GeneChip and dideoxynucleotide sequence analysis of HIV-1 genomes present in plasma samples from patients of ACTG 143 study. Int Conf AIDS. 1996 Jul 7-12;11(1):221 (abstract no TuA265)

  • Morse GD, Shelton MJ, Ho M, Bartos L, DeRemer M, Ragni M. Pharmacokinetics of zidovudine and didanosine during combination therapy. Antiviral Res. 1995 Aug;27(4):419-24. doi: 10.1016/0166-3542(95)00032-h.

    PubMed 8540760

  • Kozal M, Winters M, Shafer R, Kroodsma K, Katzenstein D, Merigan T. Behavior of codon 74 and 215 pol gene mutations in 62 AZT experienced patients on ddI monotherapy. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:55

  • Fiscus SA, DeGruttola V, Gupta P, Katzenstein DA, Meyer WA 3rd, LoFaro ML, Katzman M, Ragni MV, Reichelderfer PS, Coombs RW. Human immunodeficiency virus type 1 quantitative cell microculture as a measure of antiviral efficacy in a multicenter clinical trial. J Infect Dis. 1995 Feb;171(2):305-11. doi: 10.1093/infdis/171.2.305.

    PubMed 7844365

  • Winters MA, Shafer RW, Jellinger RA, Mamtora G, Gingeras T, Merigan TC. Human immunodeficiency virus type 1 reverse transcriptase genotype and drug susceptibility changes in infected individuals receiving dideoxyinosine monotherapy for 1 to 2 years. Antimicrob Agents Chemother. 1997 Apr;41(4):757-62. doi: 10.1128/AAC.41.4.757.

    PubMed 9087484

  • Shafer RW, Iversen AK, Kozal MJ, Winters MA, Katzenstein DA, Merigan TC. HIV-1 (HIV) isolates resistant to both AZT and ddI developing in patients receiving combination therapy contain unique pol gene mutations. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:137

  • Holodniy M, Katzenstein D, Winters M, Montoya J, Shafer R, Kozal M, Ragni M, Merigan TC. Measurement of HIV virus load and genotypic resistance by gene amplification in asymptomatic subjects treated with combination therapy. J Acquir Immune Defic Syndr (1988). 1993 Apr;6(4):366-9.

    PubMed 8095981

  • Shafer RW, Kozal MJ, Winters MA, Katzenstein DA, Ragni MV, Merigan TC. Combination therapy with ZDV+ddI suppresses virus load but does not prevent the emergence of HIV-1 isolates with ZDV resistance. ACTG 143 Protocol Virologists. Int Conf AIDS. 1993 Jun 6-11;9(1):68 (abstract no WS-B25-3)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000656, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.

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