HIV InfectionsPhase 3NCT00001104
A Study of Zidovudine in HIV-Infected Patients Who Have Hemophilia
A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 sites in United States.
Trial summary
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex… 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
- How many people
- 538 participants
- Where
- 23 sitesUnited States
- Study dates
- Start not givento Feb 1990
- Phase
- Phase 3
- 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 with caution for Study A:
- Hepatotoxic drugs.
- Patients in Study A must have:
- Hemophilia with no symptoms for AIDS. Most patients will have well-established factor 8 or 9 deficiency. However, patients with other coagulation diseases, such as factor 5 deficiency, and von Willebrand disease, will also be acceptable for the study.
- Wives in Study B are included even if they are known to be seropositive or are not sexually active at the time the study starts.
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- Prior Medication:
- Allowed for Study A:
- Patients who were on the Phase I ZDV study, ACTG 017, or are on ACTG 062 may enter after waiting 3 weeks.
Who cannot join
- Co-existing Condition:
- Patients in Study A with the following symptoms or conditions are excluded:
- AIDS-defining illness.
- Severe ARC.
- Severe or prolonged toxicity.
- Concurrent Medication:
Show all 27Show fewer
- Excluded for Study A:
- Isoniazid or rifampin.
- Treatment for Pneumocystis carinii pneumonia (PCP), oral candidiasis, and localized cutaneous herpes simplex or zoster infections.
- Probenecid.
- Aspirin on a regular basis, or for more than 72 hours without contacting the investigator.
- Drugs causing neutropenia or significant risk of nephrotoxicity.
- Patients in Study A with the following prior conditions are excluded:
- AIDS-defining opportunistic infection or malignancy.
- Unexplained temperature greater than 38 C for more than 5 consecutive days or more than 10 days in any 30-day period in the 2 years prior to entry.
- Unexplained diarrhea defined as three or more liquid stools per day, persisting more than 7 days within 2 years prior to entry.
- Unintentional weight loss of greater than 10 lbs. or more than 10 percent of usual body weight within 2 years prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Oral candidiasis unrelated to the use of antibiotic therapy for more than 2 weeks within 2 years prior to entry or within the past 3 months.
- Herpes zoster within 2 years prior to entry into the study.
- Prior Medication:
- Excluded for Study A:
- Antiretroviral agents, including ZDV, ribavirin, HPA-23, rifampin, AL721 within 8 weeks of study entry.
- Significant course of immunomodulating agents such as steroids (greater than 1 week), isoprinosine, thymic factors within 3 months of study entry.
- Any other experimental therapy within 3 months of study entry.
- Discouraged but not forbidden for Study B:
- Sexual contact with infected husband.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Baylor College of Medicine
Houston, Texas, 77030
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Minnesota
Minneapolis, Minnesota, 55455
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Cornell Univ Med Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
Univ of Washington
Seattle, Washington, 98105
Stanford Univ School of Medicine
Stanford, California, 94305
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
About this study
Official title: A Placebo Controlled Trial To Evaluate Zidovudine (ZDV) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Hemophilic Patients
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of ZDV in hemophilic patients will also be studied.
Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to his wife or other female sexual partner. To determine the effectiveness of counseling and education on the behaviors of the wives that place them at risk for HIV infection. To determine if antibodies to HIV either appear or disappear from the blood of any of the wives during the study.
Read more
Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV.
Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
Read the detailed description
Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV.
Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
Study A: Patients selected for the study are randomly assigned to placebo (inactive medication) or ZDV taken every 4 hours while the patient is awake for a total of 5 doses per day. The patient's immune function and clinical condition are monitored with periodic virus cultures, p24 antigen assays, estimates of lymphocyte type and numbers, cell surface markers, and frequent clinical evaluations to see if these are markers of drug efficacy. Patients continue on their regimen until the final analysis of the data, which could occur up to 3 years after the last patient is entered into the study. Amendment: Based on data from ACTG 019 this protocol has been closed to further accrual. All patients entered in this study will be unblinded as to treatment received. Patients will be informed of results of ACTG 019 and be requested to sign a modified statement of consent approved by the local Institutional Review Board. All patients currently receiving study therapy will be offered open-label ZDV. Patients temporarily discontinued from study therapy at this time will be offered open-label ZDV when toxicity resolves (less than or equal to Grade 2 hemoglobin or neutrophil toxicity, less than or equal to Grade 1 all other toxicities). Patients who have been permanently discontinued from study therapy will not be eligible for open-label ZDV through this protocol. Modification of dose is recommended, however, patients who elect to continue current dose of ZDV after being informed of results of ACTG 019 will be allowed to do so. All patients enrolled in this study will continue to be followed until termination of this study. Above amendment added 11/01/89.
Study B: The wife or other female sexual partner is interviewed once at the beginning of the study and again when Study A is completed. The interview takes about 10 minutes and includes questions about the couple's sexual activity to help define the risk of becoming infected with HIV. In addition, blood is drawn to test for antibodies to HIV. The questionnaire and blood sample will be repeated at the time the patient is switched from blinded study therapy to open-label ZDV. (AMENDED 11/01/89) The results of the blood test are given to the person being tested. Information about the transmission of HIV and counseling are provided. It is recommended that the wife abstain from sexual contact with her husband, but if she does not, the use of condoms or condoms plus a spermicide is recommended. The decision about the type of precautions to take does not influence the opportunity to participate in the study.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Sex Behavior, T-Lymphocytes, HIV Antibodies, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Hemophilia A
- Medical subject headings
- HIV Infections, Sexual Behavior, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionFeb 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 538 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas C. Merigan, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001104
- Sponsor's protocol ID
- ACTG 036
- Other IDs
- 11012
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Price W, Merigan T, Peterman T. Condom usage reported by female sexual partners of asymptomatic HIV seropositive hemophilic men. Int Conf AIDS. 1989 Jun 4-9;5:420 (abstract no ThBP30)
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Trial To Evaluate Zidovudine (ZDV) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Hemophilic Patients
- ClinicalTrials.gov ID
- NCT00001104
- Acronym / sponsor ID
- ACTG 036
- Conditions
- HIV Infections
- Keywords
- Sex Behavior, T-Lymphocytes, HIV Antibodies, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Hemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Feb 1990 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of ZDV in hemophilic patients will also be studied.
Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to his wife or other female sexual partner. To determine the effectiveness of counseling and education on the behaviors of the wives that place them at risk for HIV infection. To determine if antibodies to HIV either appear or disappear from the blood of any of the wives during the study.
Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV.
Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
Detailed description
Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV.
Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
Study A: Patients selected for the study are randomly assigned to placebo (inactive medication) or ZDV taken every 4 hours while the patient is awake for a total of 5 doses per day. The patient's immune function and clinical condition are monitored with periodic virus cultures, p24 antigen assays, estimates of lymphocyte type and numbers, cell surface markers, and frequent clinical evaluations to see if these are markers of drug efficacy. Patients continue on their regimen until the final analysis of the data, which could occur up to 3 years after the last patient is entered into the study. Amendment: Based on data from ACTG 019 this protocol has been closed to further accrual. All patients entered in this study will be unblinded as to treatment received. Patients will be informed of results of ACTG 019 and be requested to sign a modified statement of consent approved by the local Institutional Review Board. All patients currently receiving study therapy will be offered open-label ZDV. Patients temporarily discontinued from study therapy at this time will be offered open-label ZDV when toxicity resolves (less than or equal to Grade 2 hemoglobin or neutrophil toxicity, less than or equal to Grade 1 all other toxicities). Patients who have been permanently discontinued from study therapy will not be eligible for open-label ZDV through this protocol. Modification of dose is recommended, however, patients who elect to continue current dose of ZDV after being informed of results of ACTG 019 will be allowed to do so. All patients enrolled in this study will continue to be followed until termination of this study. Above amendment added 11/01/89.
Study B: The wife or other female sexual partner is interviewed once at the beginning of the study and again when Study A is completed. The interview takes about 10 minutes and includes questions about the couple's sexual activity to help define the risk of becoming infected with HIV. In addition, blood is drawn to test for antibodies to HIV. The questionnaire and blood sample will be repeated at the time the patient is switched from blinded study therapy to open-label ZDV. (AMENDED 11/01/89) The results of the blood test are given to the person being tested. Information about the transmission of HIV and counseling are provided. It is recommended that the wife abstain from sexual contact with her husband, but if she does not, the use of condoms or condoms plus a spermicide is recommended. The decision about the type of precautions to take does not influence the opportunity to participate in the study.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Hepatotoxic drugs.
- Hemophilia with no symptoms for AIDS. Most patients will have well-established factor 8 or 9 deficiency. However, patients with other coagulation diseases, such as factor 5 deficiency, and von Willebrand disease, will also be acceptable for the study.
- Wives in Study B are included even if they are known to be seropositive or are not sexually active at the time the study starts.
- Patients who were on the Phase I ZDV study, ACTG 017, or are on ACTG 062 may enter after waiting 3 weeks.
Key exclusion criteria (27 listed)
- AIDS-defining illness.
- Severe ARC.
- Severe or prolonged toxicity.
- Isoniazid or rifampin.
- Treatment for Pneumocystis carinii pneumonia (PCP), oral candidiasis, and localized cutaneous herpes simplex or zoster infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- BackgroundPrice W, Merigan T, Peterman T. Condom usage reported by female sexual partners of asymptomatic HIV seropositive hemophilic men. Int Conf AIDS. 1989 Jun 4-9;5:420 (abstract no ThBP30)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C. Merigan study chair
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 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 9 inclusion and 27 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 1 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 23 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00001104, which also lists 1 linked publication.
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 1 Nov 2021.