An interventional study of Methadone hydrochloride and Zidovudine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-14.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment
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Among 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) — 10 open to participants now, 15 under way, 1 of them phase 3. HIV Infections · National Institute of Allergy and Infectious Diseases (NIAID).
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 751st largest by enrollment of the 883 interventional ones that give a count, is one of 145 with no phase, and was the 1st registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →10 of the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) are open now, in 12 countries. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Peru
Ages 18–60 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–55 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Brazil, Peru
Ages 18–70
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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1,034 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 411 · Phase 2 276 · Phase 3 101 · Phase 4 10
First in 1984; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 59 across the 883 interventional studies, 174 across the 136 observational. Of the 962 that completed or were terminated, 130 (14%) have results posted.
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National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
5 of the studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06796686National Institute of Allergy and Infectious Diseases (NIAID)Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health | 2027-01-15 |
| NCT06557785National Institute of Allergy and Infectious Diseases (NIAID)A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV | 2027-03-09 |
| NCT07342491National Institute of Allergy and Infectious Diseases (NIAID)Dasatinib for HIV-1 Reservoir Reduction | 2027-04-09 |
| NCT06508749National Institute of Allergy and Infectious Diseases (NIAID)The Tatelo Plus Study | 2027-09-03 |
| NCT06665646National Institute of Allergy and Infectious Diseases (NIAID)Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706 | 2027-11-30 |
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Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), from their registry updates:
This tab as a report to print or save as PDF → With an account.
To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone therapy. In addition, the blood levels of methadone both before and during AZT treatment will be studied, and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT.
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
The 18 patients are patients with AIDS or ARC. Nine are control patients who are not receiving methadone and are not IV drug abusers. Nine are former IV drug abusers who have been maintained on methadone for at least 6 months and who have been receiving a constant daily dose of methadone for at least 1 month. Plasma and urine levels of methadone are determined over a 4 hour period. The dose of AZT: For the pharmacokinetic study of AZT, plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in the control and methadone groups.
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Prior Medication:
Allowed:
The study will include 18 patients with AIDS or -related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days.
Nine patients will be former intravenous drug abusers.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded within 72 hours of study entry:
Active drug or alcohol abuse.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is completed, as verified in Aug 1991. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methadone
National Institute of Allergy and Infectious Diseases (NIAID) →