A Phase 2 interventional study of Vitamin A in HIV Infections, Vitamin A Deficiency and HIV Seronegativity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2016-12-14.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
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 119th largest by enrollment of the 883 interventional ones that give a count, is one of 225 in phase 2, and was the 667th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 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 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: female · 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 400 is above the median of 80 across 3,489 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 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) 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.
HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus to others than HIV infected individuals who have normal levels of vitamin A. The presence of HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others. The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA in vaginal secretions.
Vitamin A deficiency leads to pathological changes in mucosal epithelium, including the vagina, and is correlated with immune dysfunction in both HIV-1 infected and uninfected individuals. Recent studies of genital tract shedding of HIV-1 DNA in infected women have found that lower serum concentrations of vitamin A were strongly associated with detection of HIV-1 in vaginal secretions. In addition, maternal vitamin A deficiency has been associated with significantly increased risk of vertical HIV-1 transmission. This study will assess the effect of vitamin A supplementation on the prevalence and quantity of HIV-1 DNA and RNA in cervical and vaginal secretions.
Participants in this study will be HIV infected nonpregnant women in Mombasa, Kenya. Participants will be randomized to receive 6 weeks of daily dosage of either 10,000 IU vitamin A or placebo. Cervical and vaginal swabs will be obtained at enrollment and at Week 6 for detection and quantification of HIV-1 DNA and RNA. In addition, venous blood will be obtained at the two time points for quantification of plasma HIV-1 RNA, CD4 lymphocyte count, and serum vitamin A levels.
Inclusion Criteria:
Exlusion Criteria:
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.
No study locations are listed for this record.
This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin A
National Institute of Allergy and Infectious Diseases (NIAID) →