HIV InfectionsPhase 1NCT00000920
Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
A Phase 1 study testing Ritonavir, Saquinavir and Lamivudine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in 2 countries.
Trial summary
The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Pregnancy
- What is being tested?
- Ritonavir, Saquinavir and Lamivudine
- How many people
- 24 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Start not givento Apr 2003
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are 14 to 32 weeks pregnant.
- Are at least 13 years old (need consent of parent or guardian if under 18).
Who cannot join
- Patients may not be eligible for this study if they:
- Cannot take ZDV, 3TC, or higher doses of RTV. Women who are able to tolerate low doses of RTV may be eligible.
- Are pregnant with more than 1 baby. (This study has been changed so that a patient pregnant with more than 1 baby is not eligible.)
- Have pregnancy complications or have medical problems that put pregnancy at risk.
- Have an active opportunistic (HIV-related) infection and/or serious bacterial infection at study entry.
- Have chronic diarrhea.
Show all 10Show fewer
- Abuse alcohol or drugs.
- Do not have access to a participating clinic or are not willing to be followed at the same clinic for the duration of the study.
- Have received certain antiretroviral (anti-HIV) drugs or are taking certain medications. (This study has been changed to increase enrollment. The eligibility criterion in earlier versions was more restrictive, and has been changed to include women receiving SQV [with or without RTV], 3TC, and ZDV for longer than 3 weeks if their pre-entry viral load is 400 copies/ml or less OR if they have a significant reduction in viral load within 90 days of the pre-entry visit.)
- Plan to breast-feed.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Children's Hosp of Michigan
Detroit, Michigan, 48201
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
Univ of Miami (Pediatric)
Miami, Florida, 33161
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Univ Hosp
New Orleans, Louisiana, 70112
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Puerto Rico1 site
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
About this study
Official title: A Phase I Trial of the Safety and Pharmacokinetics of Fortovase (Saquinavir-SGC) Co-Administered With Low Dose (Ritonavir) RTV, ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum, and in Their Infant's Post-Maternal Dosing
The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn.
Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
Read the detailed description
Although administration of ZDV to mother-infant pairs has dramatically reduced perinatal HIV infection, the goal is to reduce it further to less than 2%. In order to achieve this, combination strategies need to be developed for 2 purposes: 1) to reduce the perinatal transmission rate to goal levels; and 2) to provide other combination therapies for HIV-infected mothers whose virus has become resistant to ZDV, who have a very high viral load, or who have previously transmitted HIV while on ZDV. This study adds 3TC (another reverse transcriptase inhibitor) and SQV (a protease inhibitor [PI]) [AS PER AMENDMENT 08/15/00: with low-dose RTV (another PI)] to the mother's ZDV regimen.
During the antepartum period, mothers receive SQV with [AS PER AMENDMENT 08/15/00: low-dose RTV plus] ZDV and 3TC. At onset of active labor, mothers receive loading doses of each of the study drugs, then receive study drugs for 12 weeks postpartum on the same schedule as during the antenatal period. Within 12 hours of delivery, infants begin receiving 3TC and ZDV and continue until 6 weeks of age. Mothers are followed until 12 weeks postpartum and babies are followed until 6 months of age. [AS PER AMENDMENT 02/09/99: For maternal dosing, 1 Combivir tablet (containing 3TC and ZDV) may be administered in place of the individual agents 3TC and ZDV. Patients who prematurely discontinue study treatment should continue to be followed for the duration of the study.]
- Conditions
- HIV Infections, Pregnancy
- Being tested
- Ritonavir, Saquinavir, Lamivudine, Zidovudine
- Keywords
- Pregnancy, Drug Therapy, Combination, Zidovudine, Pregnancy Complications, Ritonavir, Lamivudine, Saquinavir, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
SaquinavirDrug
LamivudineDrug
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 completionApr 2003
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 1
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Carmen Zorrilla, Study chairArlene Bardeguez, Study chairJane Pitt, Study chairRussell Van Dyke, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000920
- Sponsor's protocol ID
- ACTG 386
- Other IDs
- 11345, PACTG 386
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Acosta EP, Zorrilla C, Van Dyke R, Bardeguez A, Smith E, Hughes M, Huang S, Pitt J, Watts H, Mofenson L; Pediatric AIDS Clinical Trials Group 386 Protocol Team. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials. 2001 Nov-Dec;2(6):460-5. doi: 10.1310/PUY3-5JWL-FX2B-98VU.
PubMed 11742433
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Safety and Pharmacokinetics of Fortovase (Saquinavir-SGC) Co-Administered With Low Dose (Ritonavir) RTV, ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum, and in Their Infant's Post-Maternal Dosing
- ClinicalTrials.gov ID
- NCT00000920
- Acronym / sponsor ID
- ACTG 386
- Conditions
- HIV Infections, Pregnancy
- Keywords
- Pregnancy, Drug Therapy, Combination, Zidovudine, Pregnancy Complications, Ritonavir, Lamivudine, Saquinavir, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Apr 2003 (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.
The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn.
Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
Detailed description
Although administration of ZDV to mother-infant pairs has dramatically reduced perinatal HIV infection, the goal is to reduce it further to less than 2%. In order to achieve this, combination strategies need to be developed for 2 purposes: 1) to reduce the perinatal transmission rate to goal levels; and 2) to provide other combination therapies for HIV-infected mothers whose virus has become resistant to ZDV, who have a very high viral load, or who have previously transmitted HIV while on ZDV. This study adds 3TC (another reverse transcriptase inhibitor) and SQV (a protease inhibitor [PI]) [AS PER AMENDMENT 08/15/00: with low-dose RTV (another PI)] to the mother's ZDV regimen.
During the antepartum period, mothers receive SQV with [AS PER AMENDMENT 08/15/00: low-dose RTV plus] ZDV and 3TC. At onset of active labor, mothers receive loading doses of each of the study drugs, then receive study drugs for 12 weeks postpartum on the same schedule as during the antenatal period. Within 12 hours of delivery, infants begin receiving 3TC and ZDV and continue until 6 weeks of age. Mothers are followed until 12 weeks postpartum and babies are followed until 6 months of age. [AS PER AMENDMENT 02/09/99: For maternal dosing, 1 Combivir tablet (containing 3TC and ZDV) may be administered in place of the individual agents 3TC and ZDV. Patients who prematurely discontinue study treatment should continue to be followed for the duration of the study.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Are HIV-positive.
- Are 14 to 32 weeks pregnant.
- Are at least 13 years old (need consent of parent or guardian if under 18).
Key exclusion criteria (10 listed)
- Cannot take ZDV, 3TC, or higher doses of RTV. Women who are able to tolerate low doses of RTV may be eligible.
- Are pregnant with more than 1 baby. (This study has been changed so that a patient pregnant with more than 1 baby is not eligible.)
- Have pregnancy complications or have medical problems that put pregnancy at risk.
- Have an active opportunistic (HIV-related) infection and/or serious bacterial infection at study entry.
- Have chronic diarrhea.
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 |
|---|---|---|
| Ritonavir | Drug | – |
| Saquinavir | Drug | – |
| Lamivudine | Drug | – |
| 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 29 Oct 2021.
- Background: PubMed 11742433Acosta EP, Zorrilla C, Van Dyke R, Bardeguez A, Smith E, Hughes M, Huang S, Pitt J, Watts H, Mofenson L; Pediatric AIDS Clinical Trials Group 386 Protocol Team. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials. 2001 Nov-Dec;2(6):460-5. doi: 10.1310/PUY3-5JWL-FX2B-98VU.
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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.
Carmen Zorrilla study chair
Arlene Bardeguez study chair
Jane Pitt study chair
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ritonavir, Saquinavir and Lamivudine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in 2 countries.
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 4 inclusion and 10 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Puerto Rico. 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 NCT00000920, 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 29 Oct 2021.